Clinical trial NCT03910907: Comparison of Standard of Care Guidelines for Mycoplasma Genitalium Infections Among Men With Non-gonococcal Urethritis
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Mycoplasma Genitalium Infection
Keywords: mycoplasma genitalium
urethritis
NGU
treatment
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with non-gonoccocal

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Participants with Molecular Clearance
timeFrame: 90 days
Secondary outcomes:
measure: Positive Participants with Macrolide-Resistant Mycoplasma
timeFrame: 90 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Barbara Van Der Pol, PhD
role: PRINCIPAL_INVESTIGATOR
References: