RecruitingPhase 2NCT07088419

"Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)"

Tinidazole for Mycoplasma Genitalium-Urethritis in the Public Health - Seattle & King County Sexual Health Clinic


Sponsor

University of Washington

Enrollment

40 participants

Start Date

Jul 23, 2025

Study Type

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

Sex: MALEMin Age: 18 Years

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

DRUGTinidazole

2 grams orally on day one followed by 500mg orally twice daily on days 2-10


Locations(1)

Harborview Medical Center, Public Health - Seattle & King County Sexual Health Clinic

Seattle, Washington, United States

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NCT07088419