Clinical trial NCT05515562: Effects of Intravenous (IV) Omadacycline on Gut Microbiome
Official title: Effects of IV Omadacycline on Gut Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Microbial Colonization
Keywords: Gut Microbiome
Clostridioides difficile
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: University of Houston
name: High Point University
name: Paratek Pharmaceuticals Inc
First posted: 2022-08-25
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 18-40 years of age
* Willing and able to comply with all study procedures
* Considered healthy without history of cardiovascular, gastrointestinal, hepatic, or renal disease
* males or females - females of child bearing potential must agree to use a highly effective contraception during the study and for at least 7 days after the last dose of omadacycline

Exclusion Criteria:

* Consumed probiotics within 30 days before enrollment
* Consumed antibiotics within 90 days prior to enrollment
* Known hypersensitivity to omadacycline or tetracycline-class antibiotics
* pregnant or breastfeeding
* 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
* previously participated in the study

Primary outcomes:
measure: Phylum Level Mean Proportional Relative Abundance
timeFrame: Day 30
measure: Phylum Level Mean Proportional Relative Abundance
timeFrame: Baseline
measure: Phylum Level Mean Proportional Relative Abundance
timeFrame: Day 5
measure: Phylum Level Mean Proportional Relative Abundance
timeFrame: Day 10
measure: Bacterial DNA Per Gram of Stool
timeFrame: Baseline
measure: Bacterial DNA Per Gram of Stool
timeFrame: During Therapy up to Day 6
measure: Bacterial DNA Per Gram of Stool
timeFrame: End of Therapy up to Day 10
measure: Order Level Mean Proportional Relative Abundance
timeFrame: Baseline
measure: Order Level Mean Proportional Relative Abundance
timeFrame: Day 5
measure: Order Level Mean Proportional Relative Abundance
timeFrame: Day 10
measure: Order Level Mean Proportional Relative Abundance
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: John C Williamson, PharmD
role: PRINCIPAL_INVESTIGATOR
References: