Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT07088419

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

Led by University of Washington · Updated on 2026-05-04

40

Participants Needed

1

Research Sites

57 weeks

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

H

Hologic, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Clinical diagnosis of non-gonococcal urethritis (NGU)
  • Positive test for urogenital Mycoplasma genitalium within the prior 7 days
  • Fluent in English
  • Assigned male at birth
  • Attending the Public Health - Seattle & King County Sexual Health Clinic
  • Able to provide informed consent
  • Able to complete a test of cure 21 days after finishing tinidazole treatment
Not Eligible

You will not qualify if you...

  • Known allergy to tinidazole
  • Other reasons that make tinidazole unsafe as determined by the doctor
  • Exclusion based on the clinician's discretion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Seattle, Washington, United States, 98104

Actively Recruiting

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Research Team

L

Lisa Manhart, PhD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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