Mycoplasma Genitalium, Non-gonococcal Urethritis (NGU)
Conditions
Keywords
Sexually Transmitted Disease (STD), Sexually Transmitted Infection (STI), Mycoplasma genitalium, Tinidazole, Non-gonococcal urethritis (NGU)
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.
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
DRUGTinidazole
2 grams orally on day one followed by 500mg orally twice daily on days 2-10
Sponsors
Hologic, Inc.
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiologic cure of M. genitalium | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antimicrobial susceptibility to tinidazole (MIC levels) | baseline; day 7; day 38 | The investigators will culture M. genitalium and determine the MIC range for tinidazole. |
| Antimicrobial susceptibility to tinidazole (resistance associated mutations) | baseline; day 7; day 38 | The investigators will use selective whole genome amplification to identify potential tinidazole resistance associated mutations (TRAMs). |
| Association of high MIC levels with treatment failure | 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. |
| Association of tinidazole resistance-associated mutations with treatment failure | 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. |
Countries
United States
Contacts
Primary ContactBella Lee
Outcome results
None listed