Microbiome Effect of Omadacycline on Healthy Volunteers

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.

Timeline

Start

2020-10-12

Primary completion

2023-09-01

Completion

2023-09-01

Publications

• Ayele H, Jo J, Begum K, Hu C, Le TM, Alam MJ, Eubank TA, Haidacher SJ, Horvath TD, Hanson BM, Garey KW. A Randomized Phase 1 Study Investigating Gut Microbiome Changes With Moxifloxacin vs Oral Vancomycin: Implications for Clostridioides difficile Risk. J Infect Dis. 2025 Dec 20;232(6):1446-1456. doi: 10.1093/infdis/jiaf512.
• Jo J, Hu C, Horvath TD, Haidacher SJ, Begum K, Alam MJ, Garey KW. Phase I trial comparing bile acid and short-chain fatty acid alterations in stool collected from human subjects treated with omadacycline or vancomycin. Antimicrob Agents Chemother. 2025 Feb 13;69(2):e0125124. doi: 10.1128/aac.01251-24. Epub 2025 Jan 17.
• Jo J, Hu C, Begum K, Wang W, Le TM, Agyapong S, Hanson BM, Ayele H, Lancaster C, Jahangir Alam M, Gonzales-Luna AJ, Garey KW. Fecal Pharmacokinetics and Gut Microbiome Effects of Oral Omadacycline Versus Vancomycin in Healthy Volunteers. J Infect Dis. 2024 Jan 12;229(1):273-281. doi: 10.1093/infdis/jiad537.

Drugs

Indications

No indication recorded.