drugset / Trial / NCT07088419

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

NCT07088419

Phase 2 Recruiting 40 enrolled University of Washington Hologic, Inc. · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-07-23
Primary completion
2026-08-01
Completion
2026-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject tinidazole Small molecule 500 mg Oral