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

Mycoplasma Genitalium Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03910907
• Other study ID #: IRB-300003178
• Status: Terminated
• Start date: November 19, 2019
• Est. completion date: March 20, 2020

Study information

• Verified date: June 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non-English speaking

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Mycoplasma Genitalium Infection
• Mycoplasma Infections
• Pleuropneumonia
• Urethritis

Intervention

Drug:
• Comparison of two standard of care regimens
Treatment according to results of laboratory detection of resistance markers

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants with Molecular Clearance	DNA negative for mycoplasma	90 days
Secondary	Positive Participants with Macrolide-Resistant Mycoplasma	DNA positive for macrolide-resistant mycoplasma	90 days