Microbiome Effect of Omadacycline on Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-12

Study Completion Date

2023-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this study is to assess microbiome changes associated with omadacycline vs. comparators (moxifloxacin or oral vancomycin). Using a phase I study design, healthy volunteers aged 18-40 years will be given a 10-day course of either omadacycline 450 mg days 1 and 2 followed by 300 mg PO once daily, moxifloxacin 400 mg once daily, or oral vancomycin 125 mg given four times daily. Stool will be collected at baseline, daily during therapy, and at two follow-up time periods (days 13-14 and days 30-32). DNA will be extracted from stool and used for qPCR biomass and microbial metagenomic experiments. Results from the study will provide definitive data on the microbiome effects of omadacycline versus comparator antibiotics.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers

NCT06462326

Healthy Volunteer

COMPLETED PHASE1

Effects of Intravenous (IV) Omadacycline on Gut Microbiome

NCT05515562

Microbial Colonization

COMPLETED PHASE4

Primary Prophylaxis of Clostridioides Difficile Infection With Oral Vancomycin

NCT07221708

Clostridioides Difficile Vancomycin Resistance Enterococcus Faecium

NOT_YET_RECRUITING PHASE2/PHASE3

Impact of Oral Antibiotic Treatment on C. Difficile

NCT02057198

C. Difficile Diarrhea Enterocolitis

COMPLETED PHASE4

Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent Recurrence of Bacterial Vaginosis

NCT03099408

Bacterial Vaginosis Recurrence

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Omadacycline

Subjects will receive 3 tablets on day 1 and day 2 (450 mg) followed by 2 tablets (300 mg) for days 3 through 10.

Group Type EXPERIMENTAL

Omadacycline

Intervention Type DRUG

10-day course

Vancomycin (oral)

Vancomycin 125 mg capsules will be taken four times daily for a total of 10 days.

Group Type ACTIVE_COMPARATOR

Vancomycin Pill

Intervention Type DRUG

10-day course

Moxifloxacin

Moxifloxacin 400 mg tablets will be taken once per day for a total of 10 days.

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

10-day course

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Omadacycline

10-day course

Intervention Type DRUG

Vancomycin Pill

10-day course

Intervention Type DRUG

Moxifloxacin

10-day course

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Exclusion. Patients will be excluded if they report any of the following:

* Cardiovascular disease
* Gastrointestinal disease
* Hepatic or renal disease
* Receipt of an antibiotic for at least three months prior to enrollment.
* Receipt of a probiotic for at least a month prior to enrollment and during the entire study period.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes