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

Recruiting now · Phase 2

Conditions studied: Mycoplasma Genitalium, Non-gonococcal Urethritis (NGU)

In brief

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.

Key facts

Study ID

NCT07088419

Run by

University of Washington

People needed

40

Starts

2025-07-23

Expected to finish

2026-08-31

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

• Known allergy to tinidazole
• Other contraindications to tinidazole
• At the clinician's discretion

Where it is running

• Harborview Medical Center, Public Health - Seattle & King County Sexual Health Clinic — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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