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

Not Applicable

Recruiting

• Conditions: Mycoplasma Genitalium; Non-gonococcal Urethritis (NGU)
• Interventions: Drug: Tinidazole

• Registration Number: NCT07088419
• Lead Sponsor: University of Washington

Brief 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.

Detailed Description

To estimate the efficacy of tinidazole for treating M. genitalium among people male sex at birth (men) diagnosed with NGU, the investigators will enroll men with NGU attending an urban sexual health clinic who have a positive test for M. genitalium. Prior to enrollment, men with NGU will have received syndromic therapy for NGU consisting of doxycycline 100mg orally twice daily for 7 days. After enrollment men with NGU will receive tinidazole 2 grams orally on day one followed by 500mg orally twice daily on days 2-10. Participants will undergo a test of cure 21 days after completing the tinidazole regimen to determine whether M. genitalium has been eradicated (microbiologic cure). Remnant urine specimens from the NGU diagnosis visit will be used to perform culture and minimum inhibitory concentration (MIC) assessment, and will undergo quantitative PCR (qPCR) to determine initial organism load. Urine specimens collected at the initiation of tinidazole therapy and at the test of cure will also undergo culture, MIC assessment, and qPCR .

Study Timeline

• Study First Submitted: 2025-05-28
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-18
• Study Start: 2025-07-23
• Last Update Submitted: 2025-07-25
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-30
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• ≥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 Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tinidazole	Tinidazole	Single Arm

Primary Outcome Measures

Name	Time	Method
Microbiologic cure of M. genitalium	Day 38	Microbiologic cure of M. genitalium will be determined at a test of cure visit. Microbiologic cure will be defined as a negative test for M. genitalium in a urine specimen using a nucleic acid amplification test.

Secondary Outcome Measures

Name	Time	Method
Antimicrobial susceptibility to tinidazole (MIC levels)	baseline; day 7; day 38	The investigators will culture M. genitalium and determine the MIC range for tinidazole.
Antimicrobial susceptibility to tinidazole (resistance associated mutations)	baseline; day 7; day 38	The investigators will use selective whole genome amplification to identify potential tinidazole resistance associated mutations (TRAMs).
Association of high MIC levels with treatment failure	Day 38	Using results from Secondary Outcome Measure #2 (culture of M. genitalium from determination of the minimum inhibitory concentration for tinidazole), the investigators will perform statistical analyses to determine if MIC levels are correlated with treatment failure.
Association of tinidazole resistance-associated mutations with treatment failure	Day 38	Using results from Secondary Outcome Measure #3, the investigators will use statistical methods to determine if specific tindazole resistance-associated mutatons are correlated with microbiologic cure.

Trial Locations

Locations (1)

Harborview Medical Center, Public Health - Seattle & King County Sexual Health Clinic; 🇺🇸 Seattle, Washington, United States