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| Name | Class |
|---|---|
| Paratek Pharmaceuticals Inc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omadacycline | Experimental | Subjects will receive 3 tablets on day 1 and day 2 (450 mg) followed by 2 tablets (300 mg) for days 3 through 10. |
|
| Vancomycin (oral) | Active Comparator | Vancomycin 125 mg capsules will be taken four times daily for a total of 10 days. |
|
| Moxifloxacin | Active Comparator | Moxifloxacin 400 mg tablets will be taken once per day for a total of 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omadacycline | Drug | 10-day course |
| |
| Vancomycin Pill |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome changes | Metagenomic changes (16S rRNA) and qPCR for individual bacterial species | During dosing and 30 day follow up period |
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Inclusion. All volunteers will be considered healthy based on medical history
Exclusion. Patients will be excluded if they report any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin W Garey | Professor and Chair | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Houston | Houston | Texas | 77204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41081530 | Derived | 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. | |
| 39819014 |
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Metagenomic and metadata will be shared by posting to relevant biorepositories or upon reasonable requests from external investigators.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2023 | Sep 1, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000591640 | omadacycline |
| D014640 | Vancomycin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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| Drug |
10-day course |
|
| Moxifloxacin | Drug | 10-day course |
|
| 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. |
| 38051631 | Derived | 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. |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |