Recruiting
Phase 2

Tinidazole

Sponsor:

University of Washington

Code:

NCT07088419

Conditions

Mycoplasma Genitalium

Non-gonococcal Urethritis (NGU)

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tinidazole

Study Details

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.

Conditions

Mycoplasma Genitalium

Non-gonococcal Urethritis (NGU)

Study ID

NCT07088419

Start date

Jul 23, 2025

Status verified date

Apr, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tinidazole

Single Arm

Interventions

Tinidazole

2 grams orally on day one followed by 500mg orally twice daily on days 2-10

Primary outcome measure

  • Microbiologic cure of M. genitalium [ Time Frame: Day 38 ]

Central Contacts and Locations

Central contacts

Lisa Manhart, PhD, MPH

206 744-3646lmanhart@uw.edu

Locations

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

Recruiting

Seattle, Washington, United States, 98104

Contacts

Bella M Lee, BS

206-744-5877bellalee@uw.edu

Principal Investigator:

Lisa E Manhart, PhD

More Information

Sponsor

University of Washington

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • Sexually Transmitted Disease (STD)
  • Sexually Transmitted Infection (STI)
  • Mycoplasma genitalium
  • Tinidazole
  • Non-gonococcal urethritis (NGU)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-05-04.