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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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

Locations
United States
Washington
Harborview Medical Center, Public Health - Seattle & King County Sexual Health Clinic
RECRUITING
Seattle
Contact Information
Primary
Bella Lee
bellalee@uw.edu
206 744-3646
Time Frame
Start Date: 2025-07-23
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 40
Treatments
Experimental: Tinidazole
Single Arm
Sponsors
Collaborators: Hologic, Inc.
Leads: University of Washington

This content was sourced from clinicaltrials.gov