RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Mycoplasma Genitalium
Intervention / Treatment

-

Contacts and Locations

Seattle

Harborview Medical Center, Public Health - Seattle & King County Sexual Health Clinic, Seattle, Washington, United States, 98104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Washington,

Lisa Manhart, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

2026-08-31