Microbiome Effect of Omadacycline on Healthy Volunteers

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Healthy Volunteers

Clinical Trial Details

NCT number	NCT06030219
Study type	Interventional
Source	University of Houston
Contact
Status	Completed
Phase	Phase 1
Start date	October 12, 2020
Completion date	September 1, 2023

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