RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-07-23
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07088419

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years of age
  2. * Clinical diagnosis of NGU
  3. * Urogenital MG documented by a positive NAAT in the prior 7 days
  4. * Fluent in English
  5. * Assigned male at birth
  6. * Attending the PHSKC SHC
  7. * Able to provide informed consent
  8. * Able to undergo a test of cure (TOC) 21 days after completing the tinidazole regimen
  1. * Known allergy to tinidazole
  2. * Other contraindications to tinidazole
  3. * At the clinician's discretion

Contacts and Locations

Study Contact

Bella Lee
CONTACT
206 744-3646
bellalee@uw.edu

Principal Investigator

Lisa Manhart, PhD
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Washington

  • Lisa Manhart, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-23
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2025-07-23
Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Mycoplasma Genitalium
  • Non-gonococcal Urethritis (NGU)