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

Last updated: July 25, 2025
Sponsor: University of Washington
Overall Status: Active - Recruiting

Phase

2

Condition

Sexually Transmitted Diseases (Stds)

Urinary Tract Infections

Treatment

Tinidazole

Clinical Study ID

NCT07088419
STUDY00021780
None, N/A
  • Ages > 18
  • Male

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  • Known allergy to tinidazole

  • Other contraindications to tinidazole

  • At the clinician's discretion

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Tinidazole
Phase: 2
Study Start date:
July 23, 2025
Estimated Completion Date:
August 31, 2026

Study 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 .

Connect with a study center

  • Harborview Medical Center, Public Health - Seattle & King County Sexual Health Clinic

    Seattle, Washington 98104
    United States

    Active - Recruiting

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