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临床试验/NCT03910907
NCT03910907终止不适用

Comparison of Current Standard of Care Versus the Australian Guidelines for Management of Mycoplasma Genitalium Infections Among Men Being Treated for Non-gonococcal Urethritis

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年11月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
1
主要终点
Participants with Molecular Clearance

研究概览

简要总结

The purpose of this protocol is to determine the difference in clearance of Mycoplasma genitalium (MG) when using the Australian management protocol versus the current Centers of Disease Control (CDC) treatment guidelines for US standard of care (SOC), to determine the proportion of men from the Deep South, with NGU attributable to MG, and to determine the proportion of MG cases that harbor the macrolide-resistance associated with mutation.

详细描述

Mycoplasma genitalium (MG) has been associated with non-gonococcal urethritis (NGU) in many populations and the prevalence of MG strains with macrolide-resistance associated gene mutations is increasing . While no MG diagnostic assays have FDA clearance in the United States (US), treatment for NGU is primarily focused on managing potential infection with Chlamydia trachomatis (CT) using single dose 1 gm Azithromycin (a macrolide class of drug). Without testing for MG that might alter NGU treatment strategies, the current paradigm may be contributing to selective pressure resulting in increased macrolide resistance in MG. In Australia, awareness of the prevalence of MG and macrolide resistance-associated mutations has been facilitated by an approved diagnostic test manufactured by SpeeDx. Ltd. As a result of the epidemiologic information generated by this diagnostic tool [MG ResistancePlus (MRP) Assay], the Australian Sexual Health Alliance, who publish the Australian Sexually Transmitted Infection (STI) Management Guidelines for Use in Primary Care, have revised the management of men with NGU and MG infection. The new management guidelines include initial treatment of NGU with doxycycline, and concomitant testing for MG and macrolide resistance, with subsequent treatment for MG infected patients according to resistance results. We propose using the MRP assay in a population of men with NGU to determine the clinical impact of the Australian treatment strategy compared to the current standard of care for NGU on clearance of MG infection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Presenting with symptoms of urethritis (dysuria and/or urethral discharge)

排除标准

  • Non-English speaking

研究组 & 干预措施

Standard of care plus

Men treated for mycoplasma according to standard of care with regimen selected based on laboratory detection of resistance markers

干预措施: Comparison of two standard of care regimens (Drug)

Standard of care

Men treated for mycoplasma according to standard of care

干预措施: Comparison of two standard of care regimens (Drug)

结局指标

主要结局

Participants with Molecular Clearance

时间窗: 90 days

DNA negative for mycoplasma

次要结局

  • Positive Participants with Macrolide-Resistant Mycoplasma(90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbara Van Der Pol

Primary Investigator

University of Alabama at Birmingham

研究点 (1)

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