The objective is to estimate the efficacy of tinidazole for the treatment of Mycoplasmagenitalium (MG) among male patients who have been diagnosed with non-gonococcalurethritis (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 totreat other infections (i.e., trichomoniasis, giardiasis, amebiasis, bacterial vaginosis)but has not been systematically tested for effectiveness against M. genitalium. Thedosing that the investigators are proposing does not significantly increase the riskassociated with taking tinidazole and this investigation meets criteria for an INDexemption.
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 .
Drug: Tinidazole
2 grams orally on day one followed by 500mg orally twice daily on days 2-10
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
Harborview Medical Center, Public Health - Seattle & King County Sexual Health Clinic
Seattle, Washington, United States
Investigator: Bella M Lee, BS
Contact: 206-744-5877
bellalee@uw.edu
Bella Lee
206 744-3646
bellalee@uw.edu
Lisa Manhart, PhD, Principal Investigator
University of Washington