"Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)"
Tinidazole for Mycoplasma Genitalium-Urethritis in the Public Health - Seattle & King County Sexual Health Clinic
University of Washington
40 participants
Jul 23, 2025
INTERVENTIONAL
Conditions
Summary
The objective is to estimate the efficacy of tinidazole for the treatment of Mycoplasma genitalium (MG) among male patients who have been diagnosed with non-gonococcal urethritis (NGU) at the Public Health - Seattle \&King County (PHSKC) Sexual Health Clinic (SHC). Tinidazole was approved by the Food and Drug Administration (FDA) in May 2004 to treat other infections (i.e., trichomoniasis, giardiasis, amebiasis, bacterial vaginosis) but has not been systematically tested for effectiveness against M. genitalium. The dosing that the investigators are proposing does not significantly increase the risk associated with taking tinidazole and this investigation meets criteria for an IND exemption.
Eligibility
Inclusion Criteria8
- ≥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 Criteria3
- Known allergy to tinidazole
- Other contraindications to tinidazole
- At the clinician's discretion
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Interventions
2 grams orally on day one followed by 500mg orally twice daily on days 2-10
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07088419