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

Recruiting in Palo Alto (17 mi)

Overseen by Barbara Van Der Pol, PhD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Barbara Van Der Pol, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

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

Treatment Details

Interventions

• Standard of Care Regimens (Antibiotic)

Participant Groups

Group I: Standard of care plus Experimental Treatment 1 Intervention

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

Group II: Standard of care Experimental Treatment 1 Intervention

Men treated for mycoplasma according to standard of care

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham