NCT Number: NCT07088419
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.
Interested in participating?
Request Info18 year and older
Male
Interventional
Phase 2
Seattle, Washington, 98104, United States
Location status: Recruiting
Bella M Lee, BS
CONTACT
Chase Cannon, MD, MPH
PRINCIPAL_INVESTIGATOR
Gwen E Wood, PhD
SUB_INVESTIGATOR
Lisa E Manhart, PhD
PRINCIPAL_INVESTIGATOR
Scott McClelland
SUB_INVESTIGATOR
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 .
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 grams orally on day one followed by 500mg orally twice daily on days 2-10
Time frame: Day 38
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.
Time frame: baseline; day 7; day 38
The investigators will culture M. genitalium and determine the MIC range for tinidazole.
Time frame: baseline; day 7; day 38
The investigators will use selective whole genome amplification to identify potential tinidazole resistance associated mutations (TRAMs).
Time frame: Day 38
Using results from Secondary Outcome Measure #2 (culture of M. genitalium from determination of the minimum inhibitory concentration for tinidazole), the investigators will perform statistical analyses to determine if MIC levels are correlated with treatment failure.
Time frame: Day 38
Using results from Secondary Outcome Measure #3, the investigators will use statistical methods to determine if specific tindazole resistance-associated mutatons are correlated with microbiologic cure.
Contact information is provided by the study sponsor or research team.
University of Washington
Other
Tinidazole for Mycoplasma Genitalium-Urethritis in the Public Health - Seattle & King County Sexual Health Clinic
Acronym: SHAZAM
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