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

NCT07088419 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: STUDY00021780None, N/A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Microbiologic cure of M. genitalium

  Microbiologic cure of M. genitalium will be determined at a test of cure visit. Microbiologic cure will be defined as a negative test for M. genitalium in a urine specimen using a nucleic acid amplification test.

  Day 38

Secondary Outcomes (4)

• Antimicrobial susceptibility to tinidazole (MIC levels)

  baseline; day 7; day 38

• Antimicrobial susceptibility to tinidazole (resistance associated mutations)

  baseline; day 7; day 38

• Association of high MIC levels with treatment failure

  Day 38

• Association of tinidazole resistance-associated mutations with treatment failure

  Day 38

Study Arms (1)

Tinidazole

EXPERIMENTAL

Single Arm

Drug: Tinidazole

Interventions

Tinidazole DRUG

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

Tinidazole

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• Hologic, Inc.: collaborator

Study Sites (1)

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

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Tinidazole

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lisa Manhart, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Manhart, PhD, MPH

CONTACT

206 744-3646; lmanhart@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Epidemiology

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: July 28, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)