Comparison of Standard of Care Guidelines for Mycoplasma Genitalium Infections Among Men With Non-gonococcal Urethritis

Terminated

• Conditions: Mycoplasma Genitalium Infection
• Interventions: Drug: Comparison of two standard of care regimens

• Registration Number: NCT03910907
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-10
• Study Start: 2019-11-19
• Primary Completion: 2020-03-20
• Study Completion: 2020-03-20
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-01
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

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

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Exclusion Criteria

• Non-English speaking

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard of care	Comparison of two standard of care regimens	Men treated for mycoplasma according to standard of care
Standard of care plus	Comparison of two standard of care regimens	Men treated for mycoplasma according to standard of care with regimen selected based on laboratory detection of resistance markers

Primary Outcome Measures

Name	Time	Method
Participants with Molecular Clearance	90 days	DNA negative for mycoplasma

Secondary Outcome Measures

Name	Time	Method
Positive Participants with Macrolide-Resistant Mycoplasma	90 days	DNA positive for macrolide-resistant mycoplasma

Trial Locations

Locations (1)

UAB; 🇺🇸 Birmingham, Alabama, United States