Tinidazole for Mycoplasma genitalium in men with non-gonococcal urethritis
Tinidazole for Mycoplasma Genitalium-Urethritis in the Public Health - Seattle & King County Sexual Health Clinic
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 |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT07088419 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seattle, Washington
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.