Tinidazole for Mycoplasma Genitalium-Urethritis in the Public Health - Seattle & King County Sexual Health Clinic
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Microbiologic cure of M. genitalium
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •Known allergy to tinidazole
- •Other contraindications to tinidazole
- •At the clinician's discretion
研究组 & 干预措施
Tinidazole
Single Arm
干预措施: Tinidazole (Drug)
结局指标
主要结局
Microbiologic cure of M. genitalium
时间窗: 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.
次要结局
- 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)
- 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)
研究者
Lisa Manhart
Professor, Epidemiology
University of Washington