Clinical Trial

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

Study acronym: SHAZAM

Recruiting Phase 2

Record status

This record was last updated May 4, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 2 amendments

This ClinicalTrials.gov record has been amended 2 times since 2025-07-18; most recent amendment 2026-04-27.

Status change: Not Yet Recruiting → Recruiting 2025-07-25

Trial Details

NCT Number	NCT07088419
Lead Sponsor	University of Washington Collaborators: Hologic, Inc.
Conditions	Mycoplasma Genitalium, Non-gonococcal Urethritis (NGU)
Enrollment	40 participants
Start Date	2025-07-23
Primary Completion	2026-08-01 (estimated)
Study Completion	2026-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-04