Tinidazole for Mycoplasma genitalium in men with non-gonococcal urethritis
Official title: Tinidazole for Mycoplasma Genitalium-Urethritis in the Public Health - Seattle & King County Sexual Health Clinic
Run by University of Washington · NCT07088419 · Data updated 2026-11-12
This study will test whether tinidazole can clear Mycoplasma genitalium infection in men diagnosed with non-gonococcal urethritis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 40 (estimated) |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Status | Recruiting |
| Started | July 23, 2025 |
| Main results expected | August 1, 2026 |
| Study ends | August 31, 2026 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT07088419 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) assigned male at birth who have clinical NGU, a documented positive NAAT for M. genitalium within the prior 7 days, attend the PHSKC Sexual Health Clinic, can consent in English, and can return for a test-of-cure 21 days after treatment.
✕Probably not a fit
People with a known allergy or other contraindication to tinidazole, those unable to return for the test-of-cure visit, or those whose infections are already highly resistant to nitroimidazoles may not receive benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will enroll adult people assigned male at birth who present to the Public Health - Seattle & King County Sexual Health Clinic with clinically diagnosed NGU and a positive NAAT for M. genitalium. Participants will have received standard syndromic therapy with doxycycline before enrollment and will then take tinidazole (2 g on day 1, then 500 mg twice daily on days 2–10). A test-of-cure visit with urine collection will occur 21 days after completing tinidazole to determine microbiologic eradication using culture, MIC testing, and quantitative PCR, and baseline remnant urine will be used to measure initial organism load and resistance. The dosing regimen uses previously FDA-approved drug parameters for other infections and the investigation qualifies for an IND exemption.
Why it matters
Potential benefit: If successful, tinidazole could become an effective oral treatment option for M. genitalium in men with NGU, potentially improving cure rates where current therapies fail or resistance is present.
How similar studies have gone: Tinidazole has not been systematically tested for M. genitalium and this approach is relatively novel compared with more-studied antibiotics like macrolides and fluoroquinolones, so direct prior evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 years of age * Clinical diagnosis of NGU * Urogenital MG documented by a positive NAAT in the prior 7 days * Fluent in English * Assigned male at birth * Attending the PHSKC SHC * Able to provide informed consent * Able to undergo a test of cure (TOC) 21 days after completing the tinidazole regimen Exclusion Criteria: * Known allergy to tinidazole * Other contraindications to tinidazole * At the clinician's discretion
Where it's running
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Harborview Medical Center, Public Health - Seattle & King County Sexual Health Clinic
Seattle, Washington, United States Recruiting
Study contacts
- Principal investigator: Lisa Manhart, PhD — University of Washington
- Study coordinator: Lisa Manhart, PhD, MPH
- Email: lmanhart@uw.edu
- Phone: 206 744-3646
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Assessing Mycoplasma genitalium infection in men who have sex with men in Hong Kong
This study is trying to understand how common Mycoplasma genitalium infections are among men who have sex with men in Hong Kong and how they spread, by having participants fill out surveys and provide samples for testing.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.