Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)

Completed · Phase 3 · Has a placebo group

Conditions studied: Urethritis

In brief

The purpose of this study is to find out which of 2 different antibiotics, doxycycline or azithromycin, works best against germs that may cause nongonococcal urethritis. Study participants will include approximately 1200 men, 16 years of age or older, attending a sexually transmitted diseases clinic in Seattle, Washington with clinical signs of urethral inflammation (\>=5PMNs/HPF on a Gram-stained slide prepared from urethral exudates and/or a visible urethral discharge upon examination). Urine specimens will be collected and tested for Mycoplasma genitalium and Ureaplasmas. Each participant will receive a blinded packet of study medication. Participants will answer an enrollment questionnaire and will also receive a log to complete between visits to record information about treatment adherence, side effects, symptoms, and sexual activity. All subjects will be asked to return for evaluation 3 weeks after the initial clinic visit. Subjects who test positive for M. genitalium and/or Ureaplasmas at the initial clinic visit will also be asked to return for a third study visit, 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis. Those who were initially positive for M. genitalium and/or Ureaplasmas will be re-tested for these organisms. Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visit will receive another blinded treatment packet containing the alternate medication. Those who require additional treatment at the 6-week visit will be asked to return for a fourth follow-up study visit at 9-10 weeks. Study participants who did not test positive for M. genitalium or Ureaplasmas at the initial clinic visit, but who continue to demonstrate signs and/or symptoms of infection at their single follow-up study visit will treated according to clinic standard of care (after the study clinician unblinds their randomly-assigned treatment regimen).

Key facts

Study ID

NCT00358462

Run by

University of Washington

People needed

606

Starts

2007-01-01

Expected to finish

2011-11-01

Last updated by the study team

2018-08-15

Who can join

Age: 16 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Has a visible urethral discharge or greater than or equal to 5 polymorphonuclear leukocytes (PMNs) per high power field on a Gram-stained slide of a urethral swab sample
• Possesses and is willing to disclose valid contact information for follow-up
• English-speaking
• Gives informed consent
• Exhibits understanding of study procedures
• Exhibits ability to comply with study procedures for the entire length of the study

You may not qualify if…

• Has previously participated in this study
• Has taken antibiotics within the prior month
• Has known allergies to tetracyclines or azithromycin
• Is being treated with any of the following: warfarin, ergot derivatives, pimozide (Orap), propafenone (Rytmonorm, Rythmol), disopyramide (Norpace, Rythmodan), rifampin, digoxin, isotretinoin, or methotrexate
• Has received a kidney, heart, or lung transplant.
• Is undertaking concomitant systemic steroid therapy

Where it is running

• Public Health -- Seattle & King County Sexually Transmitted Diseases Clinic located at Harborview Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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