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Recruiting NCT07088419

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

Phase II Interventional Mycoplasma Genitalium Non-gonococcal Urethritis (NGU)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tinidazole.
Who it may be relevant to
Registry conditions: Mycoplasma Genitalium, Non-gonococcal Urethritis (NGU). Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Detailed description

To estimate the efficacy of tinidazole for treating M. genitalium among people male sex at birth (men) diagnosed with NGU, the investigators will enroll men with NGU attending an urban sexual health clinic who have a positive test for M. genitalium. Prior to enrollment, men with NGU will have received syndromic therapy for NGU consisting of doxycycline 100mg orally twice daily for 7 days. After enrollment men with NGU will receive tinidazole 2 grams orally on day one followed by 500mg orally twice daily on days 2-10. Participants will undergo a test of cure 21 days after completing the tinidazole regimen to determine whether M. genitalium has been eradicated (microbiologic cure). Remnant urine specimens from the NGU diagnosis visit will be used to perform culture and minimum inhibitory concentration (MIC) assessment, and will undergo quantitative PCR (qPCR) to determine initial organism load. Urine specimens collected at the initiation of tinidazole therapy and at the test of cure will also undergo culture, MIC assessment, and qPCR .

Interventions

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

Primary outcome measures

  • Microbiologic cure of M. genitalium [Time frame: Day 38]
Secondary outcome measures (4)
  • Antimicrobial susceptibility to tinidazole (MIC levels) [Time frame: baseline; day 7; day 38]
  • Antimicrobial susceptibility to tinidazole (resistance associated mutations) [Time frame: baseline; day 7; day 38]
  • Association of high MIC levels with treatment failure [Time frame: Day 38]
  • Association of tinidazole resistance-associated mutations with treatment failure [Time frame: Day 38]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Harborview Medical Center, Public Health - Seattle & King County Sexual Health Clinic — Seattle

Identifiers

NCT: NCT07088419 · STUDY00021780 · None, N/A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗