Clinical trial NCT05515562
Conditions: Microbial Colonization
Keywords: Gut Microbiome Clostridioides difficile
Sponsor: Wake Forest University Health Sciences
Start date: 2023-03-20; Completion date: 2023-07-11
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Given the clinical need to improve upon current antibiotic regimens for the treatment of C. difficile infection with a particular focus on the impact of therapies on gut microbiome, this study proposes to characterize the impact of Intravenous (IV) omadacycline on gut microbiome of healthy volunteers.

Detailed description:
The plan to enroll eight healthy volunteers between the ages of 18 and 40 years and without history of cardiovascular, gastrointestinal, hepatic, or renal disease to receive 5 days of intravenous omadacycline followed by 5 days of oral omadacycline. Stool and saliva samples will be collected at pre-specified times and analyzed to characterize the impact of IV omadacycline on gut microbiome.

Arms: arm 1: All participants will receive 5 days of IV omadacycline followed by 5 days of oral omadacycline
Interventions: intervention 1: Omadacycline Injection
Intervention descriptions: intervention 1: All participants will receive Intravenous (IV) omadacycline

Protocol documents:
Prot_SAP_000.pdf: 
Omada microbiome
IRB00081259
NCT05515562
IRB Approval Date:  24APR2023


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Protocol Synopsis 
Title: Effects of IV Omadacycline on Gut Microbiome  
Version: 2.0 
Protocol Number: 001 
Version Date: 24APR2023 
Principal investigator: John C. Williamson, PharmD 
Accrual Target: 8 participants 
Population: Healthy participants between ages 18 and 40 years. 
Regimen: Participants will receive a 10-day course of omadacycline with 5 days of 
intravenous therapy followed by 5 days of oral therapy.  
Study Duration: 
Length of study: Approximately 12 months from First Participant First Visit to 
Last Participant Last Visit. 
Length of participation of study participants: Up to 36 days. 
Locations:  
University of Houston College of 
Pharmacy  
Laboratory and Data Analysis Center 
Jinhee Jo, Chenlin Hu, Anne J 
Gonzales-Luna, Khurshida Begum, 
M Jahangir Alam, and Kevin W. 
Garey 
High Point University Fred Wilson 
School of Pharmacy 
Recruitment Center 
Travis Carlson, PharmD 
Wake Forest University Health Sciences 
at Atrium Health Wake Forest Baptist 
Data and Sample Collection Center; IRB of 
record 
John Williamson, PharmD 


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1.0 STUDY OBJECTIVES  
 
 Primary Objective: 
To characterize the impact of 5 days of IV omadacycline followed by 5 days of 
oral omadacycline on the gut microbiome of healthy volunteers.  
 
2.0 BACKGROUND AND SCIENTIFIC RATIONALE 
 
Clostridioides difficile infection is a major health threat in the United States that is most 
often an outcome of perturbation of gut microbiota following antibiotic use [1]. Even the 
limited number of antibiotic regimens effective in the treatment of C. difficile infection 
have the ability to impact gut microbiome in a negative way and may increase the risk of 
relapse due to such perturbations [2,3,4]. Thus, there is an increasing need to identify 
candidate therapies for C. difficile that target this pathogen but have minimal effect on the 
native gut microbiome.  
 
Omadacycline is an aminomethylcycline tetracycline antibiotic that is approved by the 
US Food and Drug Administration (FDA) for the treatment of community-acquired 
bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections 
(ABSSSI) [5]. A recent study demonstrated in vitro activity of omadacycline against C. 
difficile [6].  
 
Given the clinical need to improve upon current antibiotic regimens for the treatment of 
C. difficile infection with a particular focus on the impact of therapies on gut microbiome, 
we propose this study to characterize the impact of IV omadacycline on gut microbiome 
of healthy volunteers. We plan to enroll healthy volunteers between the ages of 18 and 40 
years old and without history of cardiovascular, gastrointestinal, hepatic, or renal disease 
to receive 5 days of intravenous omadacycline followed by 5 days of oral omadacycline.  
 
2.1 Reproductive and Developmental Toxicity 
Based on animal data, there is reasonable suspicion that omadacycline has the potential to 
cause fetal harm [5,7]. We will only enroll females of childbearing potential who are not 
pregnant at baseline and who agree to use a reliable method of birth control or remain 
abstinent. Additionally, females of childbearing potential who use hormone-based oral 
contraceptives (OCs) will be required to use a second form of birth control (e.g. condom) 
because of a possible drug interaction with omadacycline which may lower the 
effectiveness of OCs. 
 
 


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3.0 PATIENT SELECTION  
 
3.1 Selection Criteria 
 
*Potential study volunteers who are excluded due to probiotic or antibiotic consumption may be 
re-screened at a later date when outside the exclusionary window(s). 
 
 
Investigator 
Signature 
 
Date of Signature 
(DDMMMYYYY) 
 
 
 
# 
Yes 
No Inclusion Criteria 
1 
 
 Is aged 18-40 years. 
2 
 
 Is willing and able to comply with all study procedures including providing 
informed consent, and visiting the ID Clinical Trials Center at Wake Forest 
Baptist Medical Center at the specified times to receive study medication and/or 
to deliver samples (must have reliable transportation). 
3 
 
 Is considered healthy, without history of cardiovascular, gastrointestinal, 
hepatic, or renal disease. 
4 
 
 Meets one of the three categories below:  
 1. Is female and of child 
bearing potential and agrees to 
use highly effective 
contraception during the study 
and for at least 7 days after the 
last dose of study product  
2. Is female and not of child 
bearing potential due to (One 
must be checked): 
surgical sterility OR 
congenital sterility OR  
post-menopausal state OR 
    
pre-menarchal state 
 3. Is male  
 
# 
Yes 
No Exclusion Criteria 
1 
 
 
Has consumed probiotics within 30 days prior to enrollment.* 
2 
 
 
Has consumed antibiotics within 90 days prior to enrollment.* 
3 
 
 
Has a known hypersensitivity to omadacycline or tetracycline-class 
antibacterial drugs.  
4 
 
 
Is pregnant or breastfeeding. 
5 
 
 
In the opinion of the investigator, is experiencing signs or symptoms of acute 
illness that increase the risk of adverse effects from participating in the study.  
6 
 
 
Has previously participated in the study.  


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3.2 Sample Size 
The study will enroll 8 participants.  
 
4.0 INVESTIGATIONAL PLAN 
 
4.1  Screening 
 
After signing informed consent, participants will undergo a brief interview about 
medications taken within the last 90 days with a particular focus on probiotic and 
antibiotic use. Volunteers who have received probiotics in the past 30 days and 
volunteers who have received antibiotics within the past 90 days will not be considered 
for participation. Participants will also undergo a limited review of their medical history 
to capture cardiovascular, gastrointestinal, renal, and hepatic diagnoses or conditions. 
Once the investigator confirms that the participant meets all patient selection criteria, the 
investigator and study team will schedule the patient’s first dose to occur on study Day 1. 
If dosing is to occur immediately, the participant will provide a stool sample directly 
following informed consent but before omadacycline dosing. If dosing is to occur on a 
subsequent day, the participant will bring a stool sample (obtained the morning of Day 1) 
to the clinic prior to dosing or will provide the sample in clinic just prior to Day 1 dosing.  
The screening period will begin no more than 5 days before study drug administration on 
study Day 1. 
 
4.2 Omadacycline dosing:  
 
Study Day 
Dose 
Route of administration and 
schedule 
Day 1 
200 mg 
Intravenous, infused over 60 minutes 
Days 2 – 5  
100 mg 
Intravenous, infused over 30 minutes 
Days 6 – 10  
300 mg  
Oral, two tablets once daily (dispensed 
as ten 150 mg tablets) 
 
Omadacycline powder will be provided by the sponsor, reconstituted with Sterile Water, 
and then further diluted for Injection under aseptic conditions as follows: 2 vials (200 
mg) to 2 mg/mL, and 1 vial (100 mg) to 1 mg/mL.  Each subject will receive 2 vials on 
day 1 followed by 1 vial on days 2-5 (4 additional vials). Subjects will then receive 2 oral 
tablets (300 mg) daily on study days 6 through 10 (5 days).   
 
4.3 Monitoring subjects during omadacycline infusions 
 
During the first infusion of omadacycline, subjects will be monitored by either a research 
nurse or investigator. At a minimum, the monitor will be present with the subject during 
the first 10 minutes of the infusion and will return every 5-10 minutes or sooner 
thereafter for the remainder of the 60-minute infusion. The monitoring study team 
member will, 
 
Observe the general appearance of the subject 
 
Examine skin color for possible infusion reaction 


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 
Examine the site of the infusion for possible redness or swelling 
 
Ask the subject if they are experiencing discomfort at the infusion site 
 
Ask the subject if they are experiencing any of the following symptoms: nausea, 
headache, dizziness, lightheadedness, fever, chills, shortness of breath, flushing, itching, 
or chest discomfort 
 
Report any symptoms to the investigator immediately, if investigator is not already 
present 
 
Along with investigator, assess the severity of any reported symptoms 
 
The research nurse will perform and record vital signs for any clinically significant 
symptoms. Depending on the severity of any symptoms reported, the investigator will 
determine whether the infusion should be held or discontinued. If needed, the research 
nurse or investigator will activate the institution’s code response system for “sudden 
illness” or “cardiac-pulmonary arrest”. 
 
If the subject tolerates the first infusion, subsequent infusions will be administered with 
less frequent monitoring. For these infusions, the monitoring research team member will 
be present with the subject for the first 5 minutes of the infusion and return every 10 
minutes or sooner for the remainder of the 30-minute infusion. The same approach to 
monitoring with be undertaken (see methods above). 
 
4.4 Laboratory Samples 
Female participants of childbearing potential must produce a negative urine pregnancy 
test on Day 1 prior to dosing. Results from pregnancy tests performed within 3 days prior 
to Day 1 will be accepted for eligibility. Due to the teratogenic potential of omadacycline, 
a urine pregnancy test must be repeated and confirmed negative on Day 5 prior to 
infusion. Omadacycline dosing will be discontinued if the Day 5 pregnancy test is 
positive. 
 
Participants will provide a total of 13 stool samples and 12 saliva samples during study 
participation. Two stool samples (one before and one after dosing) and one saliva sample 
will be provided on Day 1. On Days 2-10, Day 13 (+1), and Day 31 (±1) participants will 
provide the first stool sample of the day and one saliva sample per study day. Participants 
should deliver any home-collected stool samples to the clinic by 4:30pm on the day of 
collection and should store the sample in the refrigerator if not immediately bringing to 
the clinic. If the first stool sample of the day is collected after 4:30pm, it may be stored in 
the refrigerator overnight and delivered to the clinic the next morning. 


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4.5 Schedule of Events
Screening  
(-5 or 1)I 
Day 1 
Day 2 
Day 3 
Day 4 
Day 5 
Day 6 
Day 7 
Day 8 
Day 9 
Day 10 
Day 13 
(+1) 
Day 31 
(±1) 
Informed Consent 
X 
Eligibility 
X 
Enrollment 
X 
Limited Medical HistoryA 
X 
Limited Medication HistoryB 
X 
Investigational Product 
  
  
  
  
  
  
  
  
  
  
  
  
  
Omadacycline IV 200 mgC 
X 
Omadacycline IV 100 mgD 
X 
X 
X 
X 
Omadacycline Oral 300 mg 
X 
X 
X 
X 
X 
Laboratory Assessments 
  
  
  
  
  
  
  
  
  
  
  
  
  
Stool SampleE,F 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Saliva Sample  
XG 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Urine pregnancy test 
XJ 
XJ 
Safety Assessments 
  
  
  
  
  
  
  
  
  
  
  
  
  
Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant MedicationsH 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
A 
History of cardiovascular, gastrointestinal, hepatic, or renal disease is exclusionary 
B 
No probiotic consumption within 30 days of enrollment. No antibiotic consumption within 90 days prior to enrollment.  
C 
Infused over 60 minutes 
D 
Infused over 30 minutes 
E 
 
All stool samples should be delivered to the clinic less than 24 hours after collection. Delivery will typically occur the same day as collection, but could be the following morning if the sample is collected after 
4:30pm 
F 
On all study days after Day 1, the first stool of every day should be the one collected 
G 
The saliva sample on Day 1 should be provided before omadacycline dosing 
H 
Assessment of antibiotic and probiotic use to occur at each study visit 
I 
Re-screening is allowable 
J 
Results from a recent pregnancy test (within 3 days prior to Day 1) will be accepted for eligibility determination. Pregnancy tests should be performed and confirmed negative prior to dosing on Days 1 and 5. 


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4.6 Setting  
4.6.1 Recruitment and advertising  
Advertisements will be posted on the campus of High Point University (HPU) in 
High Point, NC and Atrium Health Wake Forest Baptist (AHWFB) in Winston-
Salem, NC. Study team members at HPU and AHWFB will manage recruitment. 
 
4.6.2 Study procedures  
Study procedures including informed consent, eligibility confirmation, medical 
and medication history review, investigational product dispensing and 
administration, data collection, safety monitoring, and sample collection, 
temporary storage, and shipment will take place in the Wake Forest University 
Health Sciences Infectious Diseases Clinical Trials Center (IDCTC) at the 
Winston-Salem, NC campus of Atrium Health Wake Forest Baptist.  
 
4.6.3 Laboratory and Data Analysis 
The Garey Lab at University of Houston College of Pharmacy in Houston, TX 
will perform laboratory and data analysis.  
 
5.0 SUBJECT RECRUITMENT METHODS 
Study team members at HPU and AHWFB will post advertisements, receive initial 
contact from interested study candidates, and perform pre-screening. The contact 
information of candidates who appear eligible based on pre-screening will be transferred 
to the staff of the IDCTC team for management of consent and consent process 
documentation, final sign-off on eligibility, and study enrollment.  
  
6.0 ANALYTICAL PLAN 
 
6.1 University of Houston Microbiome analysis:  
DNA extraction:  
Prior to DNA extraction, the OMNIgene tubes will be vortexed vigorously for at least 10 
seconds.  DNA will be extracted from the tube by aliquoting 300 μL of the tube sample 
using the AnaPrep system DNA extractor (AnaPrep 2, BioChain Instruments, Newark 
CA) and the following protocol.  Approximately 400 uL of lysed bacteria will be mixed 
and loaded into the AnaPrep system and gDNA will be extracted using 400 microliter 
input volume and 100 uL elution volume.  DNA will be eluted in 100μL of buffer and 
concentration measured using a Nanodrop 2000 (Fisher Scientific, Waltham, MA).  If the 
DNA concentration is less than 10 μg/mL, the extraction will be repeated. A 50 μL 
portion of the extracted DNA will be used for qPCR analysis and the remainder used for 
16S rDNA amplicon generation. 
 
High-throughput metagenomics sequencing:   
Microbiome characterization will be performed by sequencing the V3-4 region of the 16S 
rRNA gene followed by extensive bioinformatics analysis related to microbial 
composition, diversity, and community structure. Microbial DNA extraction, 16S rRNA 
gene-based next-generation sequencing (using the Illumina MiSeq), quality filtering, and 
microbiome-based analysis will be performed [8].  Each sample will be amplified using a 


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barcoded primer, which yields a unique sequence identifier tagged onto each individual 
sample library. Illumina-based sequencing will yield > 15,000 reads per sample.  
Operational taxonomic units (OTUs) will be defined as >99% identity. To analyze 
differences across timepoints, the OTU table will be normalized to the lowest number of 
sequences per sample, then consolidated by summing to species level and to each 
successively higher taxonomic level. The alpha diversity parameters Chao and Shannon 
(based on number of OTUs) and Phylogentic Diversity (PD) (based on phylogenetic 
relationships), will be generated in QIIME or R; alpha diversity is widely regarded as an 
indication of microbiota health. For beta diversity, which describes the relationships 
between samples, weighted Unifrac distance matrices will be generated in QIIME.  
 
6.2 Statistical analyses 
In general, the healthy volunteer analyses will assess changes in total and species-specific 
microbiota over time as well as changes in microbial diversity.  Significance differences 
over time will be calculated using Mann-Whitney U test.  Analyses will be performed 
using SAS (SAS Institute, Cary NC) or R on log-transformed data. The LEfSe (Linear 
Effect Size) algorithm [9] will be used to identify significant differences in microbiota 
composition between baseline and each study time point, followed by Wilcoxon Signed 
Rank tests on identified taxa. The Benjamini-Hochberg procedure will be used to control 
the false discovery rate at 0.10 [10]. The MaAsLin algorithm will be used to find 
associations of taxa with treatment. For beta diversity, principal co-ordinates analyses on 
weighted Unifrac distance matrices generated in QIIME will be performed in the vegan 
package in the statistical program R. Finally, using the methods described by Burdet at al, 
Shannon diversity (a measure of alpha diversity) will be compared at each time point for 
subjects that receive moxifloxacin or comparators[11].   
 
6.3 Omadacycline pharmacokinetics 
All subject’s stool samples will be aliquoted for omadacycline concentrations. 
 
7.0 CONFIDENTIALITY AND PRIVACY 
Confidentiality will be protected by collecting only information needed to assess study 
eligibility and outcomes, minimizing to the fullest extent possible the collection of any 
information that could directly identify subjects, and maintaining all study information in 
a secure manner. To help ensure subject privacy and confidentiality, only a unique study 
identifier will appear on the data collection form. With the exception of full names and 
signatures on the informed consent document and consent process documentation form, 
any patient information corresponding to the unique study identifier will be maintained 
and stored separately from the patient’s study chart in WFUHS’s Clinical Trials 
Management Software, OnCore or “Wake Integrated Solution for Enterprise Research 
(WISER)”.  WISER access is limited to designated study personnel.  Following data 
collection, subject identifying information will be destroyed 6 years after study closure, 
consistent with data validation and study design, producing an anonymous analytical data 
set.  Data access will be limited to study staff.  Data and records will be kept locked and 
secured, with any computer data password protected.  No reference to any individual 
participant will appear in reports, presentations, or publications that may arise from the 
study. 


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8.0 DATA AND SAFETY MONITORING 
 
8.1 Stopping Criteria for the Study 
The study will be stopped if any of the following events occur or, if in the judgment of 
the investigator, participant safety is compromised: 
 Unexpected death of a participant.  
 Occurrence of a life-threatening hypersensitivity reaction.  
 A trend of unexpected SAEs related to the study product.  
 A pattern of clinical or laboratory events considered to be associated with 
the study product that may be considered minor in terms of individual 
events but collectively represent a serious potential concern.   
 Any other event(s) that is/are considered to be SAE(s) in the clinical 
judgment of the responsible investigator.  
 
8.2 Safety 
The principal investigator will be responsible for the overall monitoring of the data and 
safety of study participants. The principal investigator and appropriately trained 
appointees will be responsible for reporting unanticipated problems (UAP), adverse 
events (AE), serious adverse events (SAE), and protocol deviations (PD) in compliance 
with Wake Forest University Health Sciences Institutional Review Board (WFUHS IRB) 
policies. All events will be logged on either a PD log or AE log as appropriate, and the 
log will be retained in the regulatory binder. A current version of the staff signature log 
and delegation of duties will be retained in the regulatory binder.  
 
In addition to ongoing reporting as UAPs, PDs, AEs, and SAEs arise, self-monitoring 
will take place at the time of IRB Continuing Review to ensure protection of rights and 
well-being of study participants and data integrity. Self-monitoring will be performed by 
the principal investigator or an appropriately trained investigator appointee with protocol 
familiarity, such as a study coordinator or project manager of the Infectious Diseases 
Clinical Trials Unit (IDCTU). Self-monitoring will include the following: 
 
 Review study file to ensure compliance with local policies. 
 Verify written informed consent is on file for each participant. 
 Review the data collection forms for completion.  
 Note any safety issues including AEs, SAEs, UAPs, and PDs and verify 
appropriate reporting took place in accordance with local requirements.  
 
9.0 REPORTING OF UNANTICIPATED PROBLEMS, ADVERSE EVENTS, OR DEVIATIONS 
 
9.1 Definitions 
 
 Adverse Event Definition:  
An AE is any untoward medical occurrence in humans, whether or not considered 
drug-related, which occurs during the conduct of a clinical trial. An AE can 
therefore be any change in clinical status, routine labs, x-rays, physical 


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examinations, etc., that is considered clinically significant by the study 
investigator. 
 
 SAE Definition:  
An SAE or serious suspected adverse reaction or serious adverse reaction as 
determined by the investigator, or the sponsor is an AE that results in any of the 
following serious outcomes: 
 Death  
 Life Threatening  
 Requiring hospitalization  
 Permanently disabling  
 Causing cancer  
 Congenital anomaly/ birth defect  
 Important medical event that may not result in one of the above outcomes, but 
may jeopardize the health of the study participant or require medical or 
surgical intervention to prevent one of the outcomes listed in the above 
definition of serious event 
 
 UAP Definition:  
An unanticipated problem is any event, incident, experience, or outcome 
(including, but not limited to, adverse events and serious adverse events) which 
occurs in a research study and meets ALL of the following criteria: 
 Unexpected in nature, frequency, or severity (not articulated in the study 
protocol, informed consent or Investigator’s Brochure or not expected as a  
consequence of the natural history of a disease under study) 
 Related or possibly related to participation in the research (there is a reasonable 
possibility the that the event, incident, experience, or outcome may have been 
caused by the drug/device, procedures or interventions involved in the 
research) 
 Places subjects or others at a greater risk of harm than was previously known 
or recognized (causes physical, psychological, economic, or social harm to a 
human subject; increases the risk of harm of any kind; or otherwise 
compromises subject's safety, rights, welfare, or privacy). 
 
9.2 Assessing Severity and Causality of AEs, SAEs, UAPs 
 
 Criteria for Assessing Severity  
The Investigator will evaluate comments of the subject and any signs or 
symptoms associated with the event occurring in response to the antibiotic in 
order to judge the nature and severity of the adverse event. Severity refers to the 
intensity of discomfort/impairment of health and will be assessed according to the 
following criteria:  
 
Mild: Awareness of sign, symptom, or event, but easily tolerated  


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Moderate: Discomfort enough to interfere with usual activity and may warrant  
intervention  
 
Severe: Incapacitating with inability to do usual activities or significantly affects  
clinical status and warrants intervention  
 
To clarify the difference between the terms "serious" and "severe", which are not  
synonymous, the following note is provided:  
 
The term "severe" is often used to describe the intensity (severity) of a 
specific event (as in mild, moderate, or severe myocardial infarction); the 
event itself, however, may be of relatively minor medical significance 
(such as severe headache). This is not the same as "serious", which is 
based on patient/event outcome or action criteria usually associated with 
events that pose a threat to a patient's life or functioning. Seriousness (not 
severity) serves as a guide for defining regulatory reporting obligations.  
 
 Criteria for Assessing Causality  
The question of the relationship of an adverse event to study drug will be 
determined by the Investigator after thorough consideration of all facts that are 
available. Assessment of causality is based on considering associative connections 
(time or place), pharmacological explanations, previous knowledge of the drug, 
presence of characteristic clinical or pathological phenomena, exclusion of other 
causes, and/or absence of alternative explanations. The causal relationship of an 
adverse event to study drug will be assessed according to the following criteria:  
The Investigator will be responsible for determining the relationship between the 
administration of study drug and the occurrence of an AE as not suspected or 
suspected.  
 
Not suspected: The temporal relationship of the adverse event to study drug 
administration makes a causal relationship unlikely, or other drugs, therapeutic 
interventions, or underlying conditions provides a sufficient explanation for the 
observed event.  
 
Not related: Temporal relationship to study drug administration is missing or 
implausible, or there is evidence of another cause.  
 
Unlikely related: Temporal relationship to study drug administration makes a 
causal relationship improbable; and other drugs, chemicals, or underlying disease 
provide plausible explanations.  
 
Suspected: The temporal relationship of the adverse event to study drug 
administration makes a causal relationship possible, and other drugs, therapeutic 
interventions, or underlying conditions do not provide a sufficient explanation for 
the observed event.  


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Possibly related: Reasonable time sequence to administration of study drug, but 
the event could also be explained by concurrent disease of other drugs or 
chemicals. Information on drug withdrawal may be lacking or unclear.  
 
Definitely related: Plausible time relationship to study drug administration; event 
cannot be explained by concurrent disease or other drugs or chemicals. The 
response to withdrawal of the drug (dechallenge) should be clinically plausible.  
 
9.3 Reporting and Monitoring of AEs or SAEs 
 Reporting of Adverse Events  
All adverse events from the time of enrollment will be recorded in the Adverse 
Events section of the case report form. All adverse events will be described in 
terms of duration, severity, possible relation to study medications and treatment.  
  
All adverse events will be followed until resolution. 
 
Pregnancies that occur while on-study will not be considered an AE, but will be 
documented. Pregnancies will be followed to outcome if outcome occurs beyond 
the participant’s Final Study Visit. Any pregnancy-associated SAE will be 
reported to the extent that information can be collected. 
 
If the adverse event meets any of the criteria for Serious Adverse Events (see 
Section 9.1), the event will also be documented on a separate SAE Form.  
 
 
Reporting of Serious Adverse Events  
In the event of a Serious Adverse Event, information will be collected and 
recorded on the Serious Adverse Event section of the case report form. Serious 
Adverse Events will be reported from the time informed consent is obtained 
through the last protocol-specified study visit; whichever occurs later.  
 
 
Serious Adverse Event (SAE) Reporting to IRB and Study Sponsor:  
The Principal Investigator will be responsible for reporting any SAE thought to be 
directly attributable to the study medication to the IRB and Study Sponsor.  
 
9.4 Deviations 
Protocol deviations not meeting the WFUHS IRB Major Protocol Deviation definition 
will be tabulated and submitted to the IRB at the time of continuing review. Deviations 
meeting the criteria of a Major Protocol Deviation as defined by the WFUHS IRB will be 
reported per WFUHS IRB Policy.  
 
 
 
 
 
 


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10.0 
REFERENCES 
 
1. Duan J, Meng X, Liu S, Zhou P, Zeng C, Fu C, et al. Gut microbiota composition associated with 
Clostridium difficile-positive diarrhea and C. difficile type in ICU patients. Front Cell Infect 
Microbiol, 11 May 2020. doi.org/10.3389/fcimb.2020.00190. 
 
2. Jacques Pépin, Marie-Eve Alary, Louis Valiquette, Evelyne Raiche, Joannie Ruel, Fulop, K., 
Dominique Godin, & Claude Bourassa. (2005). Increasing Risk of Relapse after Treatment of 
Clostridium difficile Colitis in Quebec, Canada. Clinical Infectious Diseases, 40(11), 1591–1597. 
http://www.jstor.org/stable/4484249 
 
3. Petrella LA, Sambol SP, Cheknis A, Nagaro K, Kean Y, Sears PS, Babakhani F, Johnson S, Gerding 
DN. Decreased cure and increased recurrence rates for Clostridium difficile infection caused by 
the epidemic C. difficile BI strain. Clin Infect Dis. 2012 Aug;55(3):351-7. doi: 10.1093/cid/cis430. 
Epub 2012 Apr 20. PMID: 22523271; PMCID: PMC3491778. 
 
4. Singh T, Bedi P, Bumrah K, Singh J, Rai M, Seelam S. Updates in Treatment of Recurrent 
Clostridium difficile Infection. J Clin Med Res. 2019 Jul;11(7):465-471. doi: 10.14740/jocmr3854. 
Epub 2019 Jun 11. PMID: 31236163; PMCID: PMC6575119. 
 
5. Omadacycline [package insert]. Boston, MA: Paratek Pharmaceuticals, Inc.; 2018. 
 
6. Begum, Khurshida & Bassères, Eugénie & Miranda, Julie & Lancaster, Chris & Gonzales-Luna, 
Anne & Carlson, Travis & Rashid, Tasnuva & Eyre, David & Wilcox, Mark & Alam, PhD, M. 
Jahangir & Garey, Kevin. (2020). In vitro Activity of Omadacycline, a New Tetracycline Analog, 
and Comparators Against Clostridioides difficile. Antimicrobial Agents and Chemotherapy. 64. 
10.1128/AAC.00522-20. 
 
7. Tetracycline [package insert]. Sellersville, PA: Teva Pharmaceuticals USA; 2013. 
 
8.  Fadrosh DW, Ma B, Gajer P, et al. An improved dual-indexing approach for multiplexed 16S rRNA 
gene sequencing on the Illumina MiSeq platform. Microbiome 2014; 2(1): 6. 
 
9. Segata N, Izard J, Waldron L, et al. Metagenomic biomarker discovery and explanation. Genome 
Biol 2011; 12(6): R60. 
 
10. Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach 
to multiple testing. Journal of the Royal Statistical Society Series B (Methodological) 1995; 
57(1):289±300. 
 
11. Burdet C, Nguyen TT, Duval X, et al. Impact of Antibiotic Gut Exposure on the Temporal Changes 
in Microbiome Diversity. Antimicrob Agents Chemother 2019; 63(10). 
 

ICF_001.pdf: 
Effects of Intravenous (IV) Omadacycline on Gut Microbiome
NCT05515562
IRB Approval Date:  05/08/2023


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Adult Consent Form
IRB Template Version 10JUL2019 
WFUHS Version 2.0 24APR2023
Department of Internal Medicine / Section of Infectious Diseases
EFFECTS OF IV OMADACYCLINE ON GUT MICROBIOME
Informed Consent Form to Participate in Research 
John Williamson, PharmD, Principal Investigator
SUMMARY
You are invited to participate in a research study. The purpose of this research is to better 
understand the effect that certain antibiotics have on the human microbiota. The bacteria that live 
in and on our body are known as our microbiome. This microbiome provides health benefits.
Antibiotics are life-saving in that they kill bacteria that are causing us to be ill. However, many 
antibiotics also kill the healthy bacteria microbiome. Killing of our healthy microbiota is known 
as dysbiosis. How antibiotics cause dysbiosis and steps to prevent this dysbiosis are poorly 
understood. You are invited to be in this study because you are a healthy volunteer who has not 
recently taken antibiotics. Your participation in this research involves taking a 10-day course of 
an antibiotic called omadacycline. We will collect stool and saliva samples from you prior to 
starting the antibiotic, daily while on the antibiotic, at three days after stopping the antibiotic, and 
at 21 days after stopping the antibiotic. For the first five days of participation, visits will last 
about an hour each day. On days 6-10, 13, and 31, “visits” will only consist of you delivering 
your samples to the research clinic.
Participation in this study will involve taking an antibiotic via intravenous (administered through 
your veins) and oral (by mouth) routes. All research studies involve some risks. A risk of this 
study that you should be aware of is side effects from the antibiotic. You will not benefit from 
participation in this study, but the knowledge gained from this study may help doctors use 
antibiotics in the safest possible way in the future.
Your participation in this study is voluntary. You do not have to participate in this study if you 
do not want to. The alternative is to not participate in this research. You will not lose any 
services, benefits, or rights you would normally have if you choose not to participate.
The remainder of this form contains a more complete description of this study. Please read this 
description carefully. You can ask any questions if you need help deciding whether to join the 
study. The person in charge of this study is John Williamson, PharmD. If you have questions, 
suggestions, or concerns regarding this study or you want to withdraw from the study, his contact 
information is: 
.
If you have any questions, suggestions or concerns about your rights as a volunteer in this 
research, contact the Institutional Review Board at 
 or the Research Subject 
Advocate at Wake Forest at 
.
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00081259
Meeting Date Approved 5/8/2023          
Version Valid Until: 10/9/2023


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INTRODUCTION
You are invited to be in a research study. Research studies are designed to gain scientific 
knowledge that may help other people in the future. You are being asked to take part in this 
study because you are considered a healthy volunteer who has not recently taken antibiotics or 
probiotics. Your participation is voluntary. Please take your time in making your decision as to 
whether or not you wish to participate. Ask your study doctor or the study staff to explain any 
words or information contained in this informed consent document that you do not understand. 
You may also discuss the study with your friends and family.
WHY IS THIS STUDY BEING DONE?
The purpose of this research study is to better understand the effect that an antibiotic called 
omadacycline has on the human microbiome. As part of this study, we will collect stool and 
saliva samples and evaluate the types of bacteria that live in your microbiome. As part of this 
research, we extract DNA (genetic information) from these bacterial samples. However, this 
genetic information is from the bacteria that live in your gut and NOT your human DNA.
Omadacycline has been approved by the US Food and Drug Administration (FDA) for treatment 
of certain soft tissue (e.g. skin) infections and a type of pneumonia called community-acquired 
bacterial pneumonia. However, in this study, we are investigating the impact that taking 
omadacycline has on your microbiome, rather than using it to treat an infection.
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
Eight people at will take part in this study. This study is only being done at Wake Forest University 
Health Sciences.
WHAT IS INVOLVED IN THE STUDY?
If you decide to participate, you will be asked a series of questions about your medical history 
and all medications that you have recently taken. If you are a female who is of child-bearing 
potential, your urine will be checked to make sure that you are not pregnant. This test will be 
provided by the study team. If you are eligible to continue after these questions (and a negative 
pregnancy test if you are a female of childbearing potential), you will come to the study clinic 
and be given omadacycline by IV for five days. Then, you will take omadacycline by mouth at 
home for five days.
You will also be asked to collect a stool and saliva sample that you will bring in to the study 
investigators on a daily basis while taking the antibiotic, and two more times after you are 
finished taking the antibiotic. You will be given kits (with instructions) that allow you to collect 
these samples. The samples should be immediately refrigerated and then transported to the 
research lab in a refrigerated transport container that will be provided to you. You will be asked 
to bring in a stool and saliva sample daily while you are on the antibiotics (your first 10 days of 
participation), once at 3-4 days after stopping your antibiotic, and then once at a follow-up visit 
about 21 days after you have stopped your antibiotic.
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00081259
Meeting Date Approved 5/8/2023          
Version Valid Until: 10/9/2023


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STORAGE OF BIOLOGICAL SPECIMENS
If you agree to participate in this study, we will obtain stool and saliva samples. You will deliver 
your samples to the Infectious Diseases Clinical Trials Unit staff at Wake Forest University Baptist 
Medical Center in Winston-Salem, NC. Your samples will be stored temporarily in Winston- 
Salem, NC, but will eventually be shipped to the Garey Lab at University of 
 
 for microbiome analysis. Your samples will be given only to researchers approved by the 
Garey Lab administrators. An Institutional Review Board (IRB) must approve any future research 
study using your stool and saliva samples.
The research that may be performed with your stool and saliva samples is not designed to help 
you specifically. There is no personal benefit to you from taking part in this research study. The 
knowledge gained from this study might help doctors choose antibiotics more appropriately in 
the future for people who have infections. For instance, a condition called Clostridiodes difficile 
colitis (inflammation of the colon) occurs because of dysbiosis resulting from certain antibiotics. 
Knowledge from this study may help doctors choose antibiotics that are less likely to cause 
dysbiosis and reduce the risk of C. difficile colitis. The results of the research performed with 
your stool and saliva samples will not be given to you or your doctor. The results will not be put 
in your medical record. The research using your stool and saliva samples will not affect your 
care.
Your stool and saliva samples will be used only for research and will not be sold. The findings 
from this research may result in the future development of products that are of commercial value. 
There are no plans to share any of the profits with you which may occur as a result of the 
research.
Your stool and saliva samples will be stored with a unique identifier and will not include any 
identifiable information about you such as your name, address, telephone number, social security 
number, medical record number or any of the identifiers outlined in the HIPAA Privacy Rule.
The unique identifier will be an assigned number and only the principal investigator will have 
access to the code that links the unique identifier to you. Your name, address, social security 
number, etc., will never be disclosed to future researchers and neither will the code that links 
your identifiers to the sample.
HOW LONG WILL I BE IN THE STUDY?
You will be in the study for up to 36 days.
You can stop participating at any time. If you decide to stop participating in the study we 
encourage you to talk to the investigators or study staff first to learn about any potential health or 
safety consequences. Skipping doses or not completing the full course of omadacycline may 
increase the likelihood that bacteria will develop resistance and will not be treatable by 
omadacycline or other antibacterial drugs in the future.
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00081259
Meeting Date Approved 5/8/2023          
Version Valid Until: 10/9/2023


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WHAT ARE THE RISKS OF THE STUDY?
Being in this study involves some risk to you. You should discuss the risk of being in this study 
with the study staff. The antibiotic used in this study is FDA approved for certain bacterial 
infections and is deemed safe and effective. However, all antibiotics are associated with certain 
risks including developing an infection called C. difficile infection or C. diff infection that causes 
diarrhea and colitis. Overuse of antibiotics can also lead to development of bacteria that is 
resistant to the antibiotics. However, your risk of developing C. diff infection or an antibiotic 
resistant bacterial infection is low in this study.
Other side effects observed in people who take omadacycline are more common than the more 
serious effects noted above. The following more common effects have been observed in less than 
5% of patients (5 out of every 100 patients) who have taken omadacycline:

Nausea

Vomiting

Diarrhea

Hypertension (elevated blood pressure)

Headache

Dizziness

Insomnia

Constipation

Abnormal taste

Yeast infections of the mouth or vagina

Photosensitivity (sunburn after sun exposure)
Because sunburn is possible while taking omadacycline, you should avoid prolonged exposure to 
direct sunlight and/or take precaution by applying a sunscreen to your skin before going outside.
There are some uncommon side effects that have been observed with antibiotics in the same 
family as omadacycline, e.g. tetracycline. These are possible with omadacycline and include:

Pseudotumor cerebri (increased pressure in head)

Pancreatitis (inflammation of the pancreas)
There are laboratory abnormalities that have occurred in patients taking omadacycline or other 
antibiotics in the same family as omadacycline. These include:

Increased blood urea nitrogen (BUN)

Increased phosphorus in the blood

Increased liver function tests

Increased acid in the blood

Increased pancreas enzymes in the blood

Anemia (low hemoglobin or hematocrit in blood)
For the first five days of this study, you will receive your omadacycline via intravenous infusion.
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00081259
Meeting Date Approved 5/8/2023          
Version Valid Until: 10/9/2023


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This means we will place a small tube called an intravenous (IV) catheter into your vein to allow 
for medications to be given. There are risks associated with receiving infusions. Most are mild in 
severity, although severe and even fatal reactions can occur. The most common signs and 
symptoms of infusion reactions are:

Fever and/or shaking chills

Flushing and/or itching

Alterations in heart rate and blood pressure

Difficulty breathing or chest discomfort

Back or abdominal pain

Nausea, vomiting, and/or diarrhea

Pain, redness, or swelling at the infusion site of your arm

Various types of skin rashes
In addition, there is a slight risk of a breach of confidentiality. We will do our best to protect 
your confidential information. There also may be other risks that we cannot predict. You should 
tell the research staff about all the medications, vitamins and supplements you take and any 
medical conditions you have. This may help avoid side effects, interactions and other risks.
Taking part in this research study may involve providing information that you consider 
confidential or private. Efforts, such as coding research records, keeping research records secure 
and allowing only authorized people to have access to research records, will be made to keep 
your information safe.
The use of omadacycline during the second and third trimester of pregnancy may cause 
discoloration of teeth and reversible inhibition (slowed rate) of bone growth. Omadacycline is a 
tetracycline class drug. Tetracyclines are contraindicated during pregnancy, which is why the 
study team will provide a urine pregnancy test to you if you are female and of childbearing 
potential. If your pregnancy test is positive, you will not be allowed to participate in this 
research.
Reproductive Risks and other Issues Related to Participating in Research for Women
Due to risks and potential harm to the unborn fetus caused by omadacycline, sexually active 
women of childbearing potential must use a reliable method of birth control while participating 
in this study. Reliable methods of birth control are: abstinence (not having sex), oral 
contraceptives, OrthoEvra patch, NuvaRing, intrauterine devices (IUD), Nexplanon implant, 
DepoProvera, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) 
in a monogamous relationship (same partner). An acceptable, although less reliable, method 
involves the careful use of condoms and spermicidal foam or gel and/or a diaphragm with 
spermicide with Plan B used for any noticed condom or diaphragm failures. We encourage you 
to discuss this issue further with your physicians if you have any questions.
You should not be or become pregnant while participating in this research study. We will 
provide you with a urine pregnancy test prior to starting the study and also on study day 5 to
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00081259
Meeting Date Approved 5/8/2023          
Version Valid Until: 10/9/2023


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ensure you are not pregnant. You may be asked to hold the test stick in your urine stream while 
urinating or you can collect your urine into a cup and the investigators will dip the test stick into 
it for you. A private bathroom will be provided for this purpose. You must agree to abstain from 
sex while you are taking the antibiotic and for at least 10 days after discontinuation or use 
appropriate contraception to ensure you do not become pregnant.
Contraceptive Measures for Males
Your participation in this research study may damage your sperm, which could cause harm to a 
child that you may father while on this study. Such harm may be currently unforeseeable. If you 
are sexually active, you must agree to use a medically acceptable form of birth control in order to 
be in this study and for at least 10 days after discontinuing the antibiotic. Medically acceptable 
contraceptives include: (1) surgical sterilization (such as a vasectomy), or (2) a condom used 
with a spermicide. Contraceptive measures such as Plan B (TM), sold for emergency use after 
unprotected sex, are not acceptable methods for routine use. You should inform your partner of 
the potential for harm to an unborn child. She should know that if pregnancy occurs, you will 
need to report it to the study doctor, and she should also promptly notify her doctor.
You must not donate sperm while you are taking the antibiotic and for at least 10 days after 
discontinuing the antibiotic.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
You are not expected to receive any direct benefit from taking part in this research study. We 
hope the information learned from this study will benefit other people in the future.
WHAT OTHER CHOICES ARE THERE?
You do not have to be in this study. Your alternative is to not participate in this study.
WHAT ARE THE COSTS?
All study costs, including any study medications and procedures related directly to the study, will 
be paid for by the study. Costs for your regular medical care, which are not related to this study, 
will be your own responsibility.
WILL YOUR RESEARCH RECORDS BE CONFIDENTIAL?
The results of this research study may be presented at scientific or medical meetings or published 
in scientific journals. Your identity and/or your personal health information will not be disclosed 
unless it is authorized by you, required by law, or necessary to protect the safety of yourself or 
others. There is always some risk that even de-identified information might be re-identified.
Participant information may be provided to Federal and other regulatory agencies as required. 
The Food and Drug Administration (FDA), for example, may inspect research records and learn 
your identity if this study falls within its jurisdiction.
The purpose of this research study is to obtain data or information on the effect omadacycline
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00081259
Meeting Date Approved 5/8/2023          
Version Valid Until: 10/9/2023


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has on the microbiome of healthy volunteers; the results will be provided to the sponsor, the 
Food and Drug Administration and other federal and regulatory agencies as required.
WILL YOU BE PAID FOR PARTICIPATING?
You will be paid up to $575 if you complete all the scheduled study visits. You will be paid in 
three installments.

You will be paid $100 for completing all study procedures on Day 1. This includes 
providing two stool samples, one before your dose of omadacycline, and one after.

On Day 5, you will be paid $75 for each visit you attended between Day 2 and Day 5. In 
other words, on Day 5, you will receive up to $300, depending on how many visits you 
attended from Day 2 through 5. For example, if you do not attend one of the visits 
between Days 2 and 5, you would only be paid $225 on Day 5.

On Day 31 (±1), you will be paid $25 for each sample you bring to the clinic on days 6 
through 10, Day 13(+1), and Day 31(±1). There are a total of 7 samples expected from 
Day 6 through the end of the study on Day 31(±1), which means you will be paid up to
$175 on Day 31 (±1). For example, if you do not attend one of the visits between Days 6 
and 10, you would only be paid $150 on Day 31(±1).
To receive payment, you must provide your social security number, name and address so that we 
can comply with IRS (Internal Revenue Service) reporting requirements. When payments are 
reported to the IRS we do not let them know what the payment is for, only that you have been 
paid. If you do not wish to provide this information you can still take part in this study but you 
will not be paid.
The findings from this research may result in the future development of products that are of 
commercial value. There are no plans to provide you with financial compensation or for you to 
share in any profits if this should occur.
WHO IS SPONSORING THIS STUDY?
This study is being sponsored by Paratek Pharmaceuticals. The sponsor is providing money or 
other support to Wake Forest University Health Sciences to help conduct this study. The 
researchers do not, however, hold a direct financial interest in the sponsor or the product being 
studied.
WHAT HAPPENS IF YOU EXPERIENCE AN INJURY OR ILLNESS AS A
RESULT OF PARTICIPATING IN THIS STUDY?
Should you experience a physical injury or illness as a direct result of your participation in this 
study, Wake Forest University School of Medicine maintains limited research insurance 
coverage for the usual and customary medical fees for reasonable and necessary treatment of 
such injuries or illnesses. To the extent research insurance coverage is available under this policy 
the reasonable costs of these necessary medical services will be paid, up to a maximum of
$25,000. Wake Forest University Baptist Medical Center holds the insurance policy for this 
coverage. It provides a maximum of $25,000 coverage for each claim and is limited to a total of
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00081259
Meeting Date Approved 5/8/2023          
Version Valid Until: 10/9/2023


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$250,000 for all claims in any one year. The Wake Forest University School of Medicine, and 
the North Carolina Baptist Hospitals, Incorporated do not assume responsibility to pay for these 
medical services or to provide any other compensation for such injury or illness. Additional
information may be obtained from the Medical Center’s Director of Risk and Insurance 
Management, at 
.
If you are injured, the insurer may require information such as your name, social security 
number, and date of birth in order to pay for your care. This is because the insurer is required by 
law to report any payments made to cover the care of any persons who are members of a 
government insurance plan to the Department of Health and Human Services.
You do not give up any legal rights as a research participant by signing this consent form. For 
more information on medical treatment for research related injuries or to report a study related 
illness, adverse event, or injury you should call John Williamson at 
 during 
business hours. After hours, you may contact the investigator at 
.
WHAT ABOUT MY HEALTH INFORMATION?
In this research study, any new information we collect from you and information we get from 
your medical records or other facilities about your health or behaviors is considered Protected 
Health Information. The information we will collect for this research study includes: basic 
demographic information, height and weight, dietary habits, history of cardiovascular, 
gastrointestinal, hepatic or renal disease, recent antibiotic or probiotic use, smoking and alcohol 
history, and childbearing potential status for female participants.
If this research study involves the diagnosis or treatment of a medical condition, then Protected 
Health Information collected from you during this study may be placed in your medical record, 
and may be used to help treat you, arrange payment for your care, or assist with Medical Center 
operations.
We will make every effort to keep your Protected Health Information private. We will store 
records of your Protected Health Information in a cabinet in a locked office or on a password 
protected computer.
Your personal health information and information that identifies you (“your health information”) 
may be given to others during and after the study. This is for reasons such as to carry out the 
study, to determine the results of the study, to make sure the study is being done correctly, to 
provide required reports and to get approval for new products.
Some of the people, agencies and businesses that may receive and use your health information 
are the research sponsor; representatives of the sponsor assisting with the research; investigators 
at other sites who are assisting with the research; central laboratories, reading centers or analysis 
centers; the Institutional Review Board; representatives of Wake Forest University Health 
Sciences and North Carolina Baptist Hospital; representatives from government agencies such as
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00081259
Meeting Date Approved 5/8/2023          
Version Valid Until: 10/9/2023


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the Food and Drug Administration (FDA) or the Office of Human Research Protections (OHRP), 
the Department of Health and Human Services (DHHS) and similar agencies in other countries.
Some of these people, agencies and businesses may further disclose your health information. If 
disclosed by them, your health information may no longer be covered by federal or state privacy 
regulations. Your health information may be disclosed if required by law. Your health 
information may be used to create information that does not directly identify you. This 
information may be used by other researchers. You will not be directly identified in any 
publication or presentation that may result from this study unless there are photographs or 
recorded media which are identifiable.
If required by law or court order, we might also have to share your Protected Health Information 
with a judge, law enforcement officer, government agencies, or others. If your Protected Health 
Information is shared with any of these groups it may no longer be protected by federal or state 
privacy rules.
Any Protected Health Information collected from you in this study that is maintained in the 
research records will be kept for at least six years after the study is finished. At that time any 
research information not already in your medical record will either be destroyed or it will be de- 
identified.
You can tell John Williamson that you want to take away your permission to use and share your 
Protected Health Information at any time by sending a letter to this address:
John Williamson, PharmD 
 
However, if you take away permission to use your Protected Health Information you will not be 
able to be in the study any longer. We will stop collecting any more information about you, but 
any information we have already collected can still be used for the purposes of the research 
study.
By signing this form you give us permission to use your Protected Health Information for this 
study.
If you choose to participate in this study, your medical record at Wake Forest University Baptist 
Medical Center will indicate that you are enrolled in a clinical trial. Information about the 
research and any medications or devices you are being given as a participant may also be 
included in your medical record. This part of the medical record will only be available to people 
who have authorized access to your medical record. If you are not a patient at this Medical 
Center, a medical record will be created for you anyway to ensure that this important information
WFU School of Medicine 
Institutional Review Board 
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Meeting Date Approved 5/8/2023          
Version Valid Until: 10/9/2023


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is available to doctors in case of an emergency.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This website will not include information that can identify you. At most, the 
website will include a summary of the results. You can search this Web site at any time.
A North Carolina Baptist Hospital (NCBH) medical record will be created for all study 
participants. Information about your participation in the study will be placed in the NCBH 
medical record, along with any routine medical test results that were obtained at NCBH as part 
of this study.
WHAT ARE MY RIGHTS AS A RESEARCH STUDY PARTICIPANT?
Taking part in this study is voluntary. You may choose not to take part or you may leave the 
study at any time. Refusing to participate or leaving the study will not result in any penalty or 
loss of benefits to which you are entitled. If you decide to stop participating in the study we 
encourage you to talk to the investigators or study staff first to learn about any potential health or 
safety consequences. The investigators also have the right to stop your participation in the study 
at any time. This could be because you have an unexpected reaction to the study medication.
Information that identifies you may be removed from the data or specimens that are collected as 
part of this study and could be used for future research or shared with others without additional 
consent.
You will be given any new information we become aware of that would affect your willingness 
to continue to participate in the study.
This study will be enrolling students from the High Point University campus. If you are a 
student, in addition to your rights as a research participant noted in the previous section, as a 
student, you are under no obligation to participate in this study. You may refuse to participate or 
withdraw from the study at any time and for any reason without affecting your grades, 
performance evaluations, or assignments. You will not be pressured into participating in this 
research study by any statements or implied statements that your grades, performance 
evaluations or assignments will be affected by your willingness to enroll in the study. Your 
medical records/information will not be used by the faculty, administration or study staff to make 
decisions regarding the status of your medical benefits. If you have questions regarding your 
enrollment in the study and your status as a medical student, please contact the Office of Student 
Services for additional information.
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about the study or in the event of a research-related injury, contact the study 
investigator, John Williamson at 
.
The Institutional Review Board (IRB) is a group of people who review the research to protect
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00081259
Meeting Date Approved 5/8/2023          
Version Valid Until: 10/9/2023


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your rights. If you have a question about your rights as a research participant, or you would like 
to discuss problems or concerns, have questions or want to offer input, or you want to obtain 
additional information, you should contact the Chairman of the IRB at 
 or the 
Research Subject Advocate at 
.
You will be given a copy of this signed consent form.
OPTIONAL PARTICIPATION IN FUTURE RESEARCH
In the future, people who do research may need to know more about your health. While the study 
investigator may give reports about your health, he/she will NOT be given your name, address, 
phone number, or any other identifying information about who you are, unless you agree to be 
contacted in the future.
 
YES you may contact me for future research studies 
(initials)
 
 NO I do not want to be contacted regarding future research studies. 
(initials)
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00081259
Meeting Date Approved 5/8/2023          
Version Valid Until: 10/9/2023


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SIGNATURES
I agree to take part in this study. I authorize the use and disclosure of my health information as 
described in this consent and authorization form. If I have not already received a copy of the 
Privacy Notice, I may request one or one will be made available to me. I have had a chance to 
ask questions about being in this study and my questions have been answered. By signing this 
consent and authorization form, I am not releasing or agreeing to release the investigator, the 
sponsor, the institution or its agents from liability for negligence.
Subject Name (Printed): 
Subject Signature: 
Date: 
Time: 
am pm
Person Obtaining Consent (Printed): 
Person Obtaining Consent: 
Date: 
Time: 
am pm
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00081259
Meeting Date Approved 5/8/2023          
Version Valid Until: 10/9/2023