Clinical trial NCT05977868
Conditions: Endovascular Infection Bone and Joint Infection Skin and Soft Tissue Infection Pulmonary Infection Gastrointestinal Infection Genitourinary Infection
Keywords: COpAT Oral antimicrobial therapy OPAT Parenteral antimicrobial therapy Intravenous antimicrobial therapy Implementation science
Sponsor: West Virginia University
Start date: 2023-08-04; Completion date: 2025-02-14
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an investigator initiated multisite pragmatic randomized controlled trial designed to demonstrate equivalent effectiveness with improved safety of early transition from intravenous (IV) antimicrobial therapy to complex outpatient oral antimicrobial therapy (COpAT) across various infectious diseases (endovascular, bone and joint, skin and soft tissue, pulmonary, gastrointestinal, and genitourinary infections).

All patients referred for outpatient parenteral antimicrobial therapy (OPAT) will be evaluated by the research team with respect to inclusion/exclusion criteria. If determined eligible for enrollment, patients will be approached by a study investigator who will present the COPAT Trial. Once informed consent is obtained, patients will be randomized 2:1 using computer software into experimental or control (standard of care) group, respectively: Experimental: COpAT only on hospital discharge; Control: Conventional OPAT, OPAT transitioned to COpAT later in outpatient setting, or long-acting parenteral lipoglycopeptides. Both groups will be followed by an ID physician on the research team with in-person or telemedicine ID Clinic standard of care visits at 2, 6, and 12 weeks after hospital discharge. At the 6-week ID Clinic follow-up, patients will be asked to complete a patient satisfaction survey. The following 2 primary outcomes will be assessed: cure at 3 months using clinical (resolution of infection) and laboratory (improvement in inflammatory markers) parameters and adverse events related to antimicrobial therapy/vascular access complication or readmission at 3 months. The following secondary outcome will be assessed: patient satisfaction at 6 weeks. The experimental group is being compared to standard of care in current clinical practice.

As this is a pragmatic clinical trial, patients will not undergo additional invasive testing or procedures.

Detailed description:

Arms: arm 1: COpAT (oral antimicrobial therapy) on hospital discharge arm 2: Standard of care (IV antimicrobial therapy) on hospital discharge
Interventions: intervention 1: Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid intervention 2: Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem
Intervention descriptions: intervention 1: COpAT (oral antimicrobial therapy) on hospital discharge intervention 2: Standard of care (IV antimicrobial therapy) on hospital discharge

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
Comparing Oral versus Parenteral Antimicrobial Therapy (COPAT) Trial 
NCT05977868 
 
IRB Protocol 
May 2, 2025 


    Investigator Initiated Protocol
Investigator Resources
WVU+kc Protocol #: 2304754420 
PIs: Joy J. Juskowich, MD, and Arif R. Sarwari, MD, MSc, MBA 
Protocol Number & Study Protocol Title 
Comparing Oral versus Parenteral Antimicrobial Therapy (COPAT) Trial 
WVU+kc Protocol #: 2304754420 
Table of Contents 
Section I:    Team and Research Summary 
  Study Team Composition 
 Research Summary 
Section II:   Design 
 Background & Significance 
 Objectives 
 Study Design & Methodology  
Target Population & Recruitment Methods 
Risk & Benefit 
Statistical Analysis Plan 
Safety Monitoring & Unanticipated Event Reporting 
Study Duration & Timeline 
Section III:  Informed Consent Process 
Protected Health Information (PHI) 
Informed Consent Process 
Confidentiality & Privacy 
Section IV: Other Considerations 
Conflict of Interest 
Publications & Presentations 
References 
Abbreviations List 
COPAT: Comparing Oral versus Parenteral Antimicrobial Therapy (Trial) 
COpAT: complex outpatient oral antimicrobial therapy (program) 
ID:          Infectious Diseases 
IV:          intravenous 
OPAT:   outpatient parenteral antimicrobial therapy (program) 
PO:        oral 
WVU:    West Virginia University 
Section I: Team and Research Summary 
Study Team Composition 
Principal Investigators: 
Joy J. Juskowich, MD 
Assistant Professor and COpAT Medical Director, Section of ID, WVU Department of Medicine 
Years of experience conducting research: 4 
P.O. Box 9163, Morgantown, WV 26506; phone: 304-293-1968; email: jjuskowi@hsc.wvu.edu 


    Investigator Initiated Protocol
Investigator Resources
WVU+kc Protocol #: 2304754420 
PIs: Joy J. Juskowich, MD, and Arif R. Sarwari, MD, MSc, MBA 
Arif R. Sarwari, MD, MSc, MBA 
Medical Director, WVU Positive Health Clinic 
Professor, Section of ID, WVU Department of Medicine 
Associate Dean, Clinical Affairs, WVU School of Medicine 
Years of experience conducting research: 30+ 
P.O. Box 9163, Morgantown, WV 26506; phone: 304-293-1945; email: asarwari@hsc.wvu.edu 
Co-Investigators: 
Jesse Thompson, PhD 
Research Assistant Professor, WVU Department of Medicine 
P.O. Box 9160, Morgantown, WV 26506; phone: 304-293-5610; email: jthompson8@hsc.wvu.edu 
John Guilfoose, MD 
Associate Professor, Section of ID, WVU Department of Medicine 
P.O. Box 9163, Morgantown, WV 26506; phone: 304-293-3306; email: jguilfoose@hsc.wvu.edu 
Allison Lastinger, MD 
Associate Professor, Section of ID, WVU Department of Medicine 
P.O. Box 9163, Morgantown, WV 26506; phone: 304-293-3306; email: alastinger@hsc.wvu.edu 
Jonathan Stanley, DO (United Hospital Center) 
ID Physician, United Hospital Center, WVU Medicine 
527 Medical Park Dr, STE 302, Bridgeport, WV 26330; phone: 681-342-3870; email: jonathan.stanley1@wvumedicine.org 
Connie Smith, MD, FAAP (Berkeley Medical Center) 
Assistant Professor, Section of ID-Eastern Campus, WVU Department of Medicine 
2010 Doctor Oates Drive, STE 103, Martinsburg, WV 25401; phone: 304-596-5142; email: cls0030@hsc.wvu.edu 
Victor Arcega, MD (Wheeling Hospital) 
Assistant Professor, Section of ID-Wheeling, WVU Department of Medicine 
P.O. Box 9163, Morgantown, WV 26506; phone: 304-293-3306l email: victor.arcega@hsc.wvu.edu 
Seyoum Bage, MD (Camden Clark Medical Center) 
ID Physician, Camden Clark Medical Center, WVU Medicine 
800 Grand Central Mall, STE 10, Vienna, WV 26105; phone: 304-916-1288; email: daffosb@yahoo.com 
Study Personnel: 
Manoj Nepal, PhD, CCRC 
Clinical Research Coordinator, WVU Department of Medicine 
P.O. Box 9163, Morgantown, WV 26506; phone: 304-293-5610; email: mn00023@hsc.wvu.edu 
Research Summary 
Study Population: N=135 patients (Experimental: 90 patients; Control: 45 patients); as the hypothesis is that adverse 
events will be significantly reduced in the experimental group with no significant difference in efficacy between 
groups, 135 patients (randomized 2:1) are needed to have power greater than 80%. 


    Investigator Initiated Protocol
Investigator Resources
WVU+kc Protocol #: 2304754420 
PIs: Joy J. Juskowich, MD, and Arif R. Sarwari, MD, MSc, MBA 
Inclusion (must meet all of the following): 

The patient is an adult (≥18 years) and English speaking

The patient is hospitalized at J.W. Ruby Memorial Hospital, United Hospital Center, Berkeley Medical Center, 
Wheeling Hospital, or Camden Clark Medical Center

The patient has been diagnosed with ≥1 of the following: endovascular, bone and joint, skin and soft tissue,
pulmonary, gastrointestinal, or genitourinary infection

The patient is being transitioned to 2-8 weeks of IV antibacterial therapy on hospital discharge

The patient has capacity to participate in routine OPAT/COpAT follow-up (telephone check-ins, laboratory
monitoring, and in-person or telemedicine ID Clinic follow-up)
Exclusion (may not meet any of the following): 

The patient is not appropriate for OPAT (active injection drug use, lack of infusion resources, and/or unstable
outpatient environment)

The patient is not appropriate for COpAT (unable to receive PO medication or lack of an effective PO
antimicrobial option based on susceptibility testing)

The patient is unable to give informed consent 

The patient is a prisoner, pregnant, and/or mentally handicapped

The patient is determined unsafe for enrollment at the primary team’s discretion
As noted above, children, prisoners, pregnant women, and/or mentally handicapped individuals will not be included.  
WVU/UHA/WVUH employees or WVU students may enroll in the study if inclusion/exclusion criteria are met. 
Study Design: Investigator initiated multisite pragmatic randomized controlled trial 
All patients referred for OPAT will be evaluated by the research team with respect to inclusion/exclusion criteria.  If 
determined eligible for enrollment, patients will be approached by a study investigator who will present the COPAT 
Trial.  If interested in participating in the study, patients will then complete informed consent with a member of the 
research team (study investigator or research coordinator).  Once informed consent is obtained, patients will be 
randomized 2:1 using computer software into experimental or control (standard of care) group, respectively: 
Experimental: COpAT only on hospital discharge; Control: Conventional OPAT, OPAT transitioned to COpAT later in 
outpatient setting, or long-acting parenteral lipoglycopeptides.  For patients randomized into the experimental group, 
≥2 ID physicians (principal investigators for all patients and, if at a participating hospital other than J.W. Ruby 
Memorial Hospital, also the site co-investigator) on the research team will collaborate to determine COpAT regimens.  
Both groups will be followed by an ID physician on the research team with in-person or telemedicine ID Clinic 
standard of care visits at 2, 6, and 12 weeks after hospital discharge.  At the 6-week ID Clinic follow-up, patients will 
be asked to complete a patient satisfaction survey (separate attachment).  At the 12-week ID Clinic follow-up, all 
patients who attend will receive compensation.  Data will be collected from enrollment through completion of ID 
Clinic follow-ups directly from patients as well as through patient satisfaction surveys and review of electronic medical 
records in Epic.  The study process will be identical for all participating hospitals.  As early IV to PO antimicrobial 
transition for serious infections including endocarditis and bone and joint infections is well supported by evidence 
from published clinical trials and patients will not undergo testing/procedures beyond standard of care, risk to 
patients will be minimized.  Since patients enrolled in the study will have at least one serious infection and participate 
in a randomization process with the experimental study arm evidence based but not yet as widely incorporated in 
clinical practice, more than minimal risk will be involved. 
Study Duration: 


    Investigator Initiated Protocol
Investigator Resources
WVU+kc Protocol #: 2304754420 
PIs: Joy J. Juskowich, MD, and Arif R. Sarwari, MD, MSc, MBA 
Enrollment is expected to take up to 4 months to achieve the proposed sample size.  Subjects will be followed for 3 
months after hospital discharge.  Data collection will occur in real-time throughout the study, and final data analysis 
will be performed at conclusion of the study. 
Section II: Design 
Objectives 
Purpose: To demonstrate improved safety and equivalent effectiveness of early transition from IV antimicrobial 
therapy to COpAT across various infectious diseases (endovascular, bone and joint, skin and soft tissue, pulmonary, 
gastrointestinal, and genitourinary infections) 
Primary Outcomes: Cure at 3 months using clinical (resolution of infection) and laboratory (improvement in 
inflammatory markers) parameters during ID Clinic follow-up as adjudicated by a 2-person evaluation team of ID 
faculty on the research team blinded to study arm and adverse events related to antimicrobial therapy/vascular 
access complication or readmission at 3 months.   
Secondary Outcome: Patient satisfaction using a patient satisfaction survey (separate attachment) administered at 6-
week ID Clinic follow-up.  
Rationale: Key focuses of this study are safety, effectiveness, and implementation science. 

Safety: This study will evaluate safety superiority with early transition from IV antimicrobial therapy to COpAT
versus standard of care antimicrobial therapy across various infectious diseases.

Effectiveness: This study will evaluate effectiveness equivalence between early transition from IV
antimicrobial therapy to COpAT and standard of care antimicrobial therapy across various infectious diseases.
Background & Significance 
Early IV to PO antimicrobial transition for serious infections including endocarditis and bone and joint infections is 
noninferior to prolonged IV antimicrobial therapy; this is supported by landmark studies published in the New England 
Journal of Medicine.1, 2, 3  As compared to inpatient IV antimicrobial therapy, OPAT has a similar adverse event rate but 
results in substantial cost savings.4  Challenges with IV antimicrobial therapy include vascular access requirement and 
risk of associated complications (i.e. bacteremia/fungemia and deep venous thrombosis) and social circumstance 
limitations.5  COpAT uses PO antimicrobials with high bioavailability in place of IV antimicrobials.5,6 According to 
retrospective data, early IV to PO antimicrobial transition compared to prolonged IV antimicrobial therapy for 
endocarditis has similar outcomes with fewer adverse events. 7  Our early experience at WVUH suggests COpAT is not 
only clinically effective and safer but also results in significant additional cost savings.6 However, unlike OPAT, COpAT 
programs are not yet widely incorporated into clinical practice.  In addition, clinical trials evaluating safety superiority 
with equivalent effectiveness of early IV to PO antimicrobial transition across various infectious diseases are lacking.  
The COPAT Trial is designed to demonstrate equivalent effectiveness with improved safety of early transition from IV 
antimicrobial therapy to COpAT across various infectious diseases (endovascular, bone and joint, skin and soft tissue, 
pulmonary, gastrointestinal, and genitourinary infections); we hypothesize that adverse events will be significantly 
reduced in patients discharged from the hospital with COpAT versus standard of care with no significant difference in 
efficacy between groups.  Should results of the COpAT Trial support the hypothesis, the evidence may promote more 
widespread incorporation of COpAT programs into clinical practice, improving patient care and resulting in lower cost 
of care. 


    Investigator Initiated Protocol
Investigator Resources
WVU+kc Protocol #: 2304754420 
PIs: Joy J. Juskowich, MD, and Arif R. Sarwari, MD, MSc, MBA 

Implementation Science: Conducting this study will promote development of COpAT programs at additional
WVU Medicine institutions.  Should this study prove our hypothesis, COpAT programs will be more widely
incorporated into clinical practice.
Study Design & Methodology 
This is an investigator initiated multisite pragmatic randomized controlled trial designed to demonstrate equivalent 
effectiveness with improved safety of early transition from IV antimicrobial therapy to COpAT across various 
infectious diseases (endovascular, bone and joint, skin and soft tissue, pulmonary, gastrointestinal, and genitourinary 
infections).  Primary and secondary outcome data will be collected prospectively. 
All patients referred for OPAT will be evaluated by the research team with respect to inclusion/exclusion criteria.  If 
determined eligible for enrollment, patients will be approached by a study investigator who will present the COPAT 
Trial.  If interested in participating in the study, patients will then complete informed consent with a member of the 
research team (study investigator or research coordinator after collaborating with a study investigator).  Once 
informed consent is obtained, patients will be randomized 2:1 using computer software into experimental or control 
(standard of care) group, respectively: Experimental: COpAT only on hospital discharge; Control: Conventional OPAT, 
OPAT transitioned to COpAT later in outpatient setting, or long-acting parenteral lipoglycopeptides.  For patients 
randomized into the experimental group, ≥2 ID physicians (principal investigators for all patients and, if at a 
participating hospital other than J.W. Ruby Memorial Hospital, also the site co-investigator) on the research team will 
collaborate to determine COpAT regimens.  Both groups will be followed by an ID physician on the research team with 
in-person or telemedicine ID Clinic standard of care visits at 2, 6, and 12 weeks after hospital discharge.  At the 6-
week ID Clinic follow-up, patients will be asked to complete a patient satisfaction survey (separate attachment).  At 
the 12-week ID Clinic follow-up, all patients who attend will receive compensation.  
The following primary outcomes will be assessed: cure at 3 months using clinical and laboratory parameters during ID 
Clinic follow-up as adjudicated by a 2-person evaluation team of ID faculty blinded to study arm and adverse events 
related to antimicrobial therapy/vascular access complication (defined as any adverse event requiring intervention) or 
readmission at 3 months.  The following secondary outcome will be assessed: Patient satisfaction using a patient 
satisfaction survey administered at 6-week ID Clinic follow-up (separate attachment).  Data will be collected from 
patients directly as well as through patient satisfaction surveys and review of electronic medical records in Epic. 
Early IV to PO antimicrobial transition, as will be performed in the experimental group, has been proven clinically 
effective for serious infections including endocarditis and bone and joint infections.  According to retrospective data, 
early IV to PO transition compared to prolonged IV antimicrobial therapy for endocarditis has been shown to have 
similar outcomes with fewer adverse events.  In addition, retrospective chart review of the first 100 patients who 
completed the WVUH COpAT program, showed low failure and side effect/adverse events rates.  The experimental 
group is being compared to standard of care in current clinical practice.  As this is a pragmatic clinical trial, patients 
will not undergo additional invasive testing or procedures.  The probability and magnitude of harm or discomfort 
anticipated in this study are not greater in and of themselves than those ordinarily encountered in daily life while 
undergoing treatment for serious infection(s).  Therefore, risk to patients will be minimized.  Since patients enrolled in 
the study will have at least one serious infection and participate in a randomization process with the experimental 
study arm evidence based but not yet as widely incorporated in clinical practice, more than minimal risk will be 
involved. 
There may be no direct benefit to study participants with the exception that patients randomized to the experimental 
group may be discharged from the hospital sooner and have improved safety.  This research will make a significant 


    Investigator Initiated Protocol
Investigator Resources
WVU+kc Protocol #: 2304754420 
PIs: Joy J. Juskowich, MD, and Arif R. Sarwari, MD, MSc, MBA 
contribution to the field of ID as more prospective data supporting early IV to PO antimicrobial transition for serious 
infections is needed to change practice. 
Target Population & Recruitment Methods 
Sample Size: As the hypothesis is that adverse events will be significantly reduced in the experimental group with no 
significant difference in efficacy between groups, 135 patients (Experimental: 90 patients; Control: 45 patients) are 
needed to have power greater than 80%. 
Inclusion & Exclusion Criteria: 
Inclusion (must meet all of the following): 

The patient is an adult (≥18 years) and English speaking

The patient is hospitalized at J.W. Ruby Memorial Hospital, United Hospital Center, Berkley Medical Center,
Wheeling Hospital, or Camden Clark Medical Center

The patient has been diagnosed with ≥1 of the following: endovascular, bone and joint, skin and soft tissue,
pulmonary, gastrointestinal, or genitourinary infection

The patient is being transitioned to 2-8 weeks of IV antimicrobial therapy on hospital discharge

The patient has capacity to participate in routine OPAT/COpAT follow-up (telephone check-ins, laboratory
monitoring, and in-person or telemedicine ID Clinic follow-up)
Exclusion (may not meet any of the following): 

The patient is not appropriate for OPAT (active injection drug use, lack of infusion resources, and/or unstable
outpatient environment)

The patient is not appropriate for COpAT (unable to receive PO medication or lack of an effective PO
antimicrobial option based on susceptibility testing)

The patient is unable to give informed consent 

The patient is a prisoner, pregnant, and/or mentally handicapped

The patient is determined unsafe for enrollment at primary team’s discretion
Vulnerable Populations: 

As noted in the above inclusion/exclusion criteria, children, prisoners, pregnant women, and/or mentally
handicapped individuals will not be included in this study.

WVU/UHA/WVUH employees or WVU students may enroll in the study if inclusion/exclusion criteria are met.
Recruitment: All patients referred for OPAT will be evaluated by the research team with respect to 
inclusion/exclusion criteria.  If determined eligible for enrollment, patients will be approached by a study investigator 
who will present the COPAT Trial.  If interested in participating in the study, patients will then complete informed 
consent with a member of the research team (study investigator or research coordinator after collaborating with a 
study investigator). 
Risk & Benefit 
Risk: Patients may experience standard of care adverse events related to antimicrobial therapy and/or vascular access 
device, lack of infection resolution, or infection recurrence.  No study-related adverse events expected.  There is 
always the risk of uncommon or previously unknown side effect(s) or adverse event(s).  Other possible risks and 
discomforts include experiences associated with IV antibiotic use such as need for IV access, more time required to 


    Investigator Initiated Protocol
Investigator Resources
WVU+kc Protocol #: 2304754420 
PIs: Joy J. Juskowich, MD, and Arif R. Sarwari, MD, MSc, MBA 
take each dose, and number of doses per day.  Similarly, possible risks and discomforts associated with oral antibiotic 
use may include experiences associated with pill size and number of doses per day.  IV and oral antibiotics have 
similar side effects. 
If an infection is not improving or a patient is having major side effects, treatment may be changed to IV antibiotics (if 
a patient is receiving oral) or oral antibiotics (if a patient is receiving IV). 
Benefit: Patients may be discharged from the hospital sooner and have a reduced risk of adverse events related to 
vascular access device if randomized to the experimental group. 
Statistical Analysis Plan 
Sample Size: As the hypothesis is that adverse events will be significantly reduced in the experimental group with no 
significant difference in efficacy between groups, 135 patients (Experimental: 90 patients; Control: 45 patients) are 
needed to have power greater than 80%.  Calculations were performed through consultation with a biostatistician 
using failure and adverse event rates for COpAT/PO antimicrobial therapy taken from data presented and published 
on 100 patients who completed the WVUH COpAT Program and for conventional/intravenous antimicrobial therapy 
taken from clinical trial data published on serious infections including endocarditis and bone and joint infections. 
Sample Size Allocation: As the study will be conducted across 5 WVU Medicine hospitals, the number of subjects each 
site expects to enroll is as follows: J.W. Ruby Memorial Hospital 90 patients, United Hospital Center 18 patients, 
Berkeley Medical Center 12 patients, Wheeling Hospital 9 patients, Camden Clark Medical Center 6 patients. 
Data Safety Monitoring: A Data and Safety Monitoring Plan will be implemented to facilitate ongoing review of the 
study, actions, data collection, and analysis throughout the entirety of the project.  It will include details regarding 
handling serious adverse events (SAEs)/adverse events (AEs).  A Data Safety Monitoring Board (DSMB) has been 
formed to oversee subject safety including one member not on the research team who is an expert in the field of ID: 
Michael Stevens, MD, MPH, FSHEA, FIDSA, FACP, WVU Health System’s System Healthcare Epidemiologist and 
Associate Chief Quality Officer for Infection Prevention and Antimicrobial Stewardship and WVU Professor of Internal 
Medicine and Public Health, accepted his nomination to serve this role.  The DSMB will review data and provide 
monitoring at 3 points in the study: after 45 patients are enrolled, after 90 patients are enrolled, and after 135 
patients are enrolled. 
Early Stopping and Selection: Bayesian statistical model will be used to assess efficacy outcomes and adverse events 
in the interim analysis.  In particular, the predictive probability (for the final sample size) of primary outcomes will be 
estimated, given the current data.  Denoting the posterior probabilities of adverse event outcome p1 (Control Arm) 
and p2 (Experimental Arm), respectively; the posterior probabilities of efficacy outcome by q1 (Control Arm) and q2 
(Experimental Arm), respectively.  
If Prob {p1>p2 | data} >0.90 and Prob{ |q1 – q2| < 0.10 |data} > 0.90, 
then the trial will be stopped early, and the experimental arm will be selected as superior arm.  
Safety Monitoring & Unanticipated Event Reporting 
In addition to the DSMB, the principal investigators will be responsible for data quality management and safety 
monitoring.  At hospitals other than J.W. Ruby Memorial Hospital, site co-investigators will provide enrollment reports 


    Investigator Initiated Protocol
Investigator Resources
WVU+kc Protocol #: 2304754420 
PIs: Joy J. Juskowich, MD, and Arif R. Sarwari, MD, MSc, MBA 
to the principal investigators weekly and report any serious events to the principal investigators immediately.  The 
principal investigators will then report any adverse or unanticipated events to the IRB in conjunction with 
requirements outlined by the IRB.  The principal investigators will chair a monthly meeting including collaborating site 
co-investigators to ensure all data entry for current subjects is complete and up to date, review safety data including 
all serious events, and discuss all protocol deviations. 
Study Duration & Timeline 
Study Duration: 
Enrollment is expected to take 4 months to achieve our proposed sample size.  Subjects will be followed for 3 months 
after hospital discharge.  Data collection will occur in real-time throughout the study, and final data analysis will be 
performed at conclusion of the study. 
Section III: Informed Consent Process 
Protected Health Information (PHI) 
Our study will require dealing with PHI, including names, medical record numbers, dates, and phone numbers.  PHI 
will not be used for data analysis or reported/published.  All PHI will be kept confidential. 
Informed Consent Process 
All patients referred for OPAT will be evaluated by the research team with respect to inclusion/exclusion criteria.  If 
determined eligible for enrollment, patients will be approached by a study investigator who will present the COPAT 
Trial.  If interested in participating in the study, patients will then complete informed consent with a member of the 
research team (study investigator or research coordinator after collaborating with a study investigator). 
Based on inclusion/exclusion criteria for the study, all patients will be adults (≥18 years) and able to give informed 
consent.  Therefore, only patients themselves will grant consent to participate.  Informed consent will require a 
written signature from patients with the exception of patients unable to write due to a physical condition including 
but not limited to infection involving the dominant hand in which case verbal consent may be accepted and 
documented on the consent form with a witness present. 
Confidentiality & Privacy 
Confidentiality: All data will be kept for 3 years after the conclusion of the research project.  Any physical copies of 
data collected will be kept in a locked drawer or file cabinet within a locked room or office.  Digital data will be 
encrypted on a password protected database/drive.  All patient identifiers will be stored separately from data 
collected. 
Privacy: Conversations with patients while hospitalized will be conducted in the privacy of their own hospital rooms.  
Telephone check-ins with patients for OPAT/COpAT monitoring (standard of care) will be conducted from a private 
office with the door closed.  ID Clinic follow-ups will be conducted in private clinical exam rooms.  Data will be kept 
safe and secure according to the process explained in the above section. 
Section IV: Other Considerations 


    Investigator Initiated Protocol
Investigator Resources
WVU+kc Protocol #: 2304754420 
PIs: Joy J. Juskowich, MD, and Arif R. Sarwari, MD, MSc, MBA 
Conflict of Interest 
The research team does not have any conflicts of interest to report. 
Publications & Presentations 
The research team plans for results of this research to be presented at IDWeek 2024 and submitted for publication in 
either Clinical Infectious Diseases or the New England Journal of Medicine. 
References 
1.
Iverson K, Ihlemann N, Gill SU, et al. Partial Oral versus Intravenous Antibiotic Treatment of Endocarditis. N
Engl J Med. 2019;380(5):415-424. doi: 10.1056/NEJMoa1808312
2.
Li HK, Rombach I, Zambellas R, et al. Oral versus Intravenous Antibiotics for Bone and Joint Infection. N Engl J
Med. 2019;380(5):425-436. doi: 10.1056/NEJMoa1710926
3.
Rosenvinge F, Helweg-Larsen, J, Fosbol, EL, et al. Five-Year Outcomes of the Partial Oral Treatment of
Endocarditis (POET) Trial. N Engl J Med. 2022;386(6):601-602. doi: 10.1 
4.
Staples JA, Ho M, Ferris D, et al. Outpatient versus Inpatient Intravenous Antimicrobial Therapy: A Population-
Based Observational Cohort Study of Adverse Events and Costs. Clin Infect Dis. 2022;75(11):1921-1929. doi:
10.1093/cid/ciac298
5.
Rivera CG, Mehta M, Ryan KL, et al. Role of infectious diseases pharmacists in outpatient intravenous and
complex oral antimicrobial therapy: Society of Infectious Diseases Pharmacists insights. J Am Coll Clin Pharm.
2021;4:1161-1169. doi: 10.1002/jac5.1473
6.
Juskowich JJ, Ward A, Spigelmyer A, et al. Complex Outpatient Oral Antimicrobial Therapy (COpAT) Program at 
a Rural Academic Medical Center: Evaluation of First 100 Patients. Open Forum Infect Dis. 2022; 9(2): S418-
S419. doi: 10.1093/ofid/ofac492.843
7.
Freling S, Wald-Dickler N, Banerjee J, et al. Real-world Application of Oral Therapy for Infective Endocarditis: A
Multicenter Retrospective, Cohort Study. Clin Infect Dis. 2023; ciad119. doi: 10.1093/cid/ciad119.

ICF_001.pdf: 
 
 
 
 
Comparing Oral versus Parenteral Antimicrobial Therapy (COPAT) Trial 
NCT05977868 
 
Informed Consent Form 
June 12, 2024 


WVU+kc Protocol #: 2304754420 
 Funding Source: WVU Department of Medicine 
Medical Informed Consent for Research 
Key Information for: 
Comparing Oral versus Parenteral Antimicrobial Therapy (COPAT) Trial 
You are being asked to participate as a human subject in the research described below. This page 
provides a summary of the research that may help you to decide whether you wish to participate. 
More detailed information can be found in the Informed Consent Form beginning on the next 
page.  
What is the study about and how long will it last? 

The purpose of this study is to determine if early transition from intravenous (IV) to oral
antibiotics is safer while treating your infection successfully as well compared to
continued outpatient IV antibiotics.

You will be asked to agree to be randomized (like flipping a coin) to be discharged with
oral antibiotics or outpatient IV antibiotics to complete treatment for your infection.  As a
part of either group (and per usual care), you will receive telephone calls to see how you
are doing, have weekly lab tests for monitoring, and follow up in person or by telephone
or video in Infectious Diseases (ID) Clinic.

Your participation in this study is expected to last 3 months after you are discharged from
the hospital.
Do you have to participate, and what are the benefits and risks? 
Participation in this research study is entirely voluntary, and you are free to withdraw from the 
research at any time.  If you do not wish to participate, please discuss alternatives with Joy J. 
Juskowich, MD, or Arif R. Sarwari, MD, MSc, MBA, or refer to the "Alternatives" section in the 
consent form.  If you choose to withdraw your participation from the research study, the data 
collected about you will remain a part of the research database and may not be removed.  No 
additional information will be added to the database after you withdraw. 
Benefits from participation may include leaving the hospital sooner or having lower risk of 
complications related to IV access if you are randomized to the group discharged with oral 
antibiotics.  Knowledge gained from this study may eventually benefit others. 
Risks from participation in this study include: adverse events related to antibiotics or IV access, 
lack of infection resolution, or infection recurrence (same as with usual treatment for your 
infection).  Other possible risks and discomforts include experiences associated with IV 
antibiotic use such as need for IV access, more time required to take each dose, and number of 
doses per day.  Similarly, possible risks and discomforts associated with oral antibiotic use may 
include experiences associated with pill size and number of doses per day.  IV and oral 
antibiotics have similar side effects. 
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02/2023 V4.0 
Who can you talk to if you have questions or concerns? 
If you have any questions or concerns about this research or wish to withdraw, you can contact: 
Research Study Contact Name: Joy J. Juskowich, MD, or Arif R. Sarwari, MD, MSc, MBA, 
from West Virginia University (WVU) Department of Medicine, Section of ID, at 304-293-3306 
(Ext. 3) or jjuskowi@hsc.wvu.edu.  Business Hours: Monday-Friday 9:00 AM-4:30 PM. 
For more information, please review the Informed Consent Form on the next page. 
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WVU+kc Protocol #: 2304754420 
Funding Source: WVU Department of Medicine 
02/2023 V4.0  
Medical Informed Consent for Research 
Principal Investigators (PIs) | Joy J. Juskowich, MD, and Arif R. Sarwari, MD, MSc, MBA 
Department | 
WVU Department of Medicine, Section of ID 
Co-Investigator(s) | 
Jesse Thompson, PhD, John Guilfoose, MD, Allison Lastinger, 
MD, Jonathan Stanley, DO, Connie Smith, MD, FAAP, Victor Arcega, MD, Seyoum Bage, MD 
Sponsor or Funding Source | WVU Department of Medicine 
WVU IRB Protocol # | 
2304754420 
Research Study Title | 
Comparing Oral versus Parenteral Antimicrobial Therapy 
(COPAT) Trial 
Introduction 
You have been asked to participate in this research study. The research has been explained to 
you by an authorized member of the research team.  
This research is being conducted by Joy J. Juskowich, MD, and Arif R. Sarwari, MD, MSc, 
MBA, from WVU Department of Medicine, Section of ID.  Funding for this research is provided 
by WVU Department of Medicine. 
What is the purpose of this study? 
The purpose of this research is to determine if early transition from intravenous (IV) to oral 
antibiotics is safer while treating your infection as well compared to continued outpatient IV 
antibiotics.  For serious infections including heart infections and bone and joint infections, early 
transition from IV to oral antibiotics has been shown to be as good as IV antibiotics only.  IV 
antibiotics after you leave the hospital are associated with challenges including need for IV 
access and possible complications.  Oral antibiotics that reach high blood levels may be used in 
place of IV antibiotics. 
All medications used in this study are approved by the Food and Drug Administration (FDA) for 
the treatment of serious infections.   
WVU expects to enroll approximately 135 participants in the research study across 5 
participating WVU Medicine hospitals.  
What will you be asked to do? 
If you decide to take part, this is what will happen: 
This research study involves being treated for your infection at the time of your hospital 
discharge with oral antibiotics or outpatient IV antibiotics.  You will be followed for 
approximately 3 months. 
If you are being asked to participate in this research study, you have been diagnosed with an 
infection.  By taking part in this research study, you will be randomized (like flipping a coin) to 
receive either oral antibiotics only from the time of hospital discharge or outpatient IV 
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WVU+kc Protocol #: 2304754420 
Funding Source: WVU Department of Medicine 
02/2023 V4.0 
antibiotics, which may be any of the following: IV antibiotics only, IV antibiotics changed to 
oral antibiotics later (sometime after hospital discharge), or longer-acting IV antibiotics.  As a 
part of either group (and per usual care), you will receive telephone calls to see how you are 
doing, have weekly lab tests for monitoring, and be followed by an Infectious Diseases (ID) 
physician on the research team with in-person or telemedicine ID Clinic visits at 2, 6, and 12 
weeks after hospital discharge.   
If your infection is not improving or you are having major side effects, your treatment may be 
changed to IV antibiotics (if receiving oral) or oral antibiotics (if receiving IV). 
At the 6-week ID Clinic follow-up, you will be asked to complete a short patient satisfaction 
survey expected to take 5 minutes or less.  You may skip any questions you do not wish to 
answer and stop taking the survey at any time.  You may request to access and review the patient 
satisfaction survey prior to signing this Informed Consent Form. 
Incidental Findings 
As part of usual care, any clinically relavent medical information such as results from lab tests 
and routine ID care will be discussed with you during follow-up calls or ID Clinic visits. 
What are the possible risks and discomforts? 
As is the case with standard of care antibiotic treatment for infection, risks from participating in 
this study include adverse events related to antibiotics or IV access, lack of infection resolution, 
and/or infection recurrence.  There is always the risk of uncommon or previously unknown side 
effect(s) or adverse event(s).  Other possible risks and discomforts include experiences 
associated with IV antibiotic use such as need for IV access, more time required to take each 
dose, and number of doses per day.  Similarly, possible risks and discomforts associated with 
oral antibiotic use may include experiences associated with pill size and number of doses per 
day.  IV and oral antibiotics have similar side effects. 
If you don’t want to take part in this study, are there other choices? 
An alternative would be to not participate in this study.  Participation in this study is voluntary; 
you do not have to participate. 
Will you benefit from taking part in this study? 
You may or may not directly benefit from participating in this research.  Benefits from 
participation may include leaving the hospital sooner or having lower risk of complications 
related to IV access if you are randomized to the group discharged with oral antibiotics.  The 
knowledge gained from this research may eventually benefit others. 
What will it cost you to participate? 
There are no additional costs for participating in this research study. 
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WVU+kc Protocol #: 2304754420 
Funding Source: WVU Department of Medicine 
Participants should consult with their insurance carrier before participation.  Any expense 
associated with current therapy or treatment of side effects will be billed to you or your insurance 
company the same way as it would be if you were not participating in this research study. 
Will you receive any payment for taking part in this study? 
You will be paid $50 in the form of a gift card for participating in this study and attending your 
ID Clinic follow-up visit 12 weeks after hospital discharge.  Your visit may be in person or by 
telephone or video.  If you do not participate in your ID Clinic follow-up visit 12 weeks after 
hospital discharge, you will be paid $0.  For more information regarding the method of payment, 
contact the Principal Investigators. 
Unless the research is confidential or awarded an NIH Certificate of Confidentiality, you may be 
asked to provide your Social Security Number and verification of U.S. Citizenship or Permanent 
Resident Status to receive payment.  
Your information may be provided to the appropriate parties for billing and/or payment 
purposes.  Please be advised that any compensation received for participation in a research study 
is considered taxable income and must be reported to the Internal Revenue Service (IRS).  A 
form 1099 will be sent to you if your total payments for research participation are $600 or more 
in a calendar year. 
Your data, health information, research results, specimens, genomic data, or any and other 
information related to this research or used in this research study may contribute to a discovery 
or treatment. In some instances, your data, your health information, your research results, your 
specimens, the discoveries or treatments, or any other information related to this research study 
(even if identifiers are removed) may be of commercial value.  The information may be sold, 
patented, or licensed by the Principal Investigators, and West Virginia University for use in other 
research or the development of new products. You will not retain any property rights, and you 
will not be eligible to share in any monetary or commercial profit that the Principal Investigators, 
West Virginia University, or their agents may realize. 
Who will see the information that you give? 
We will keep your information as confidential as possible.  However, if the law requires that we 
disclose your confidential information, every effort will be made to limit the use and disclosure 
of the information.  Your name will not be used in the publication of information about the 
research. 
Your research records and test results, just like hospital records, could be subpoenaed by court 
order or may be inspected by the study sponsor or federal regulatory authorities without your 
additional consent. 
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WVU+kc Protocol #: 2304754420 
Funding Source: WVU Department of Medicine 
There are instances where the researcher is legally required to provide information to the 
appropriate authorities. This could include the mandatory reporting of infectious diseases and 
information about behavior that is imminently dangerous to you or others, such as suicide, child 
abuse, etc. 
All data collected in this research study including records identifying the pateints will be kept 
safe and secure.  Any physical copies of data collected will be kept in a locked drawer or file 
cabinet within a locked room or office.  Digital data will be stored on a password protected 
database or drive.  All information that may be used to identify you will be stored separately 
from data collected. 
Regarding the patient satisfaction survey, we will make every effort to safeguard your data, but 
as with anything online, we cannot guarantee the security of data transmitted via the Internet. 
Third-party applications used in this study may have Terms of Service and Privacy policies 
outside of the control of West Virginia University.  We will be using a secure web-based data 
collection tool designed for research (REDCap). 
Will your information be used for future research? 
Your information or biospecimen collected as part of this research, even if identifiers are 
removed, will not be used or distributed for future research. 
ClinicalTrials.gov 
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 web 
site will include a summary of the results. You can search the website at any time. 
HIPAA Authorization 
West Virginia University is dedicated to protecting the privacy of your information. As part of 
the protection, we are required to obtain your written authorization (permission) before we may 
use or disclose your protected health information (PHI) or share it for research purposes. 
You can decide to sign or not to sign this authorization. However, if you choose not to sign this 
authorization, you will not be able to take part in the research. The choice you make about 
participation in this research study will not affect your access to medical care. 
Persons/Organizations Providing the Information: 
Data will be obtained from both of the following: 
Patient – Data is obtained from the participant. 
West Virginia University Hospitals\WVU Medicine\WVUHS – Data is obtained from medical 
records. 
Persons/Organizations Receiving the Information: 
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WVU+kc Protocol #: 2304754420 
Funding Source: WVU Department of Medicine 
•
The research site(s) carrying out this study.  This includes: UHA or UHA Affiliates,
WVU, WVU Hospitals, West Virginia University Health System (WVUHS), and other
affiliate sites, including the research and medical staff at the site(s).
•
Health care providers who provide services to you as part of this research study.
•
Laboratories and others that view your health information as part of this study in
agreement with the study protocol.
•
U.S. Department of Health and Human Services (which includes the National Institutes
of Health (NIH), Food and Drug Administration (FDA), and other groups that have the
right to use the information as required by law.
•
The members and staff of the Institutional Review Board that oversees this research
study.
•
The West Virginia University Office of Human Research Protections and the West
Virginia University Office of Sponsored Programs.
•
The WVU Department of Medicine, Section of ID.
The Following Information Will Be Used:  
This information could include new or existing information about you, such as demographic 
data, history and physicals, progress notes, consultation notes, operative reports, clinic visit 
notes, laboratory results, microbiology results, x-rays and other imaging results, cardiovascular 
study results, and study forms.  
The Information is Being Disclosed for the Following Reasons: 
•
Review of your data for quality assurance purposes
•
Publication of study results (without identifying you)
•
Other research purposes such as reviewing the safety or effectiveness of the study or
therapies, conducting performance reviews of the study, evaluating other therapies for
patients, developing a better understanding of infectious diseases and their treatment,
and/or improving the design of future clinical trials.
You may cancel this HIPAA Authorization at any time by writing to the Principal 
Investigators. 
All cancellations must be in writing. 
Principal Investigators’ Names: Joy J. Juskowich, MD, and Arif R. Sarwari, MD, MSc, MBA 
Mailing Address: P.O. Box 9163, Morgantown, WV 26506 
If you cancel this Authorization, any information that has been collected for the research study to 
date cannot be withdrawn.  Once information is disclosed, according to this Authorization, the 
recipient may re-disclose it, and then the information may no longer be protected by federal 
regulations. 
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WVU+kc Protocol #: 2304754420 
Funding Source: WVU Department of Medicine 
02/2023 V4.0 
You have a right to see and make copies of your medical records. You will not be able to see or 
copy your records related to the research study until all work related to the study has been 
completed.  At that time, you may ask to see the information related to your participation and 
request corrections to the information.  
This Authorization will expire at the end of the research study unless you cancel it before that 
time. 
What happens if you get hurt or sick during the study? 
If you are injured as a result of this research, treatment will be available.  This care will be billed 
to you or your insurance company.  There is no commitment from WVU to provide any 
compensation for research-related injury.  You should realize, however, that you have not 
released this institution from liability for negligence.  Please contact the Principal Investigators, 
Joy J. Juskowich, MD, or Arif R. Sarwari, MD, MSc, MBA, at 304-293-3306 (Ext. 3) during 
business hours or 304-598-4000 after business hours if you are injured or sick (related to 
participation) for further information. 
Who should you contact if you have questions or concerns? 
If you have any questions, concerns, or complaints about this research, contact 
Principal Investigators’ Names: Joy J. Juskowich, MD, and Arif R. Sarwari, MD, MSc, MBA 
Telephone Number: 304-293-3306 (Ext. 3) 
Business Hours: Monday-Friday 9:00 AM-4:30 PM 
If an injury occurs or you become sick (related to participation), contact 
During Business Hours 
Principal Investigators’ Names: Joy J. Juskowich, MD, and Arif R. Sarwari, MD, MSc, MBA 
Telephone Number: 304-293-3306 (Ext. 3) 
Outside of Business Hours 
Principal Investigators’ Names: Joy J. Juskowich, MD, and Arif R. Sarwari, MD, MSc, MBA 
Telephone Number: 304-598-4000 
For information regarding your rights as a participant in research or to talk about the research, 
contact the WVU Office of Human Research Protections (OHRP) at (304) 293-7073 or by email 
at IRB@mail.wvu.edu. 
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WVU+kc Protocol #: 2304754420 
Funding Source: WVU Department of Medicine 
02/2023 V4.0 
Do you have to participate in this study? 
Participation in this research study is voluntary. You are free to withdraw your consent to 
participate at any time.  f you withdraw or do not wish to participate, your future care or status at 
West Virginia University will not be affected. 
In the event new information becomes available that may affect your willingness to participate in 
this research, the information will be given to you so that you can make an informed decision 
about whether or not to continue your participation. 
If you choose to withdraw your participation from the research study, the data collected about 
you will remain a part of the research database and may not be removed.  No additional 
information will be added to the database after you withdraw. 
For WVU Students as participants: 
If you do not wish to participate or if you choose to withdraw, your class standing, and grades 
will not be affected and will involve no penalty to you. 
For WVU Employees as participants: 
If you do not wish to participate or choose to withdraw, your employment status at West Virginia 
University will not be affected. 
Do you want to be contacted with information about future studies? 
Future research may be conducted for which you may be eligible. If you are interested in being 
contacted for future research, please indicate so by completing this section. Leaving the box 
blank is seen as NOT giving consent. 
☐Yes, I want to be contacted.
☐No, I do not want to be contacted.
Signatures
Participant Signature Section 
I willingly consent to participate in this research and applicable authorizations. Upon signing this 
form, you will receive a copy. 
Printed Name: 
Signature:  
Date: 
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WVU+kc Protocol #: 2304754420 
Funding Source: WVU Department of Medicine 
02/2023 V4.0 
Legally Authorized Representative Signature Section (delete this section if not applicable) 
The participant is unable to give informed consent. I, as the legally authorized representative of 
the participant, give consent for their participation in this study. 
Printed Name: 
Signature:  
Date: 
Consenting Individual Signature Section (Authorized Staff) 
The participant has had the opportunity to have questions addressed. The participant willingly 
agrees to be in the study. 
Printed Name: 
Signature: 
Date: 
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