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

NCT ID: NCT03910907

Last Updated: 2023-06-02

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-19
• Study Completion Date: 2020-03-20

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.

Conditions

Mycoplasma Genitalium Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Standard of care

Men treated for mycoplasma according to standard of care

Comparison of two standard of care regimens

Intervention Type: DRUG

Treatment according to results of laboratory detection of resistance markers

Standard of care plus

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

Comparison of two standard of care regimens

Intervention Type: DRUG

Treatment according to results of laboratory detection of resistance markers

Interventions

Comparison of two standard of care regimens

Treatment according to results of laboratory detection of resistance markers

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Non-English speaking

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Barbara Van Der Pol

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara Van Der Pol, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

IRB-300003178

Identifier Type: -

Identifier Source: org_study_id