Clinical Trial: Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Mycoplasma Genitalium Antibiotic Susceptibility and Treatment: A Randomized Double-blind Trial of the Efficacy of Azithromycin and Doxycycline for Clinical and Microbiolog

Brief Summary:

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 Ureapla

Detailed Summary:

OBJECTIVES

The primary objective of this study is to determine the relative effectiveness of azithromycin and doxycycline in eradicating Mycoplasma genitalium and Ureaplasmas among men with nongonococcal urethritis (NGU).

Secondary objectives of this study are to:

  • determine the sensitivity of persisting organisms to azithromycin and doxycycline by performing minimum inhibitory concentration (MIC) testing
  • determine the relationship between persistence/recurrence of clinical signs and persistent/recurrent detection of M. genitalium and Ureaplasmas among men with NGU treated with azithromycin or doxycycline, measured by follow-up clinical exams and repeated assays performed on specimens collected at follow-up study visits

STUDY DESCRIPTION

1200 men with NGU, ages 16 and older, will be enrolled in a randomized double-blinded treatment trial. Urine samples, oral swabs, and urethral swabs will be obtained from each subject at the initial clinic visit. Urine specimens will be tested for M. genitalium and Ureaplasma. Study participants will be randomly assigned to receive one of two pre-packaged treatments: active doxycycline plus placebo azithromycin or active azithromycin plus placebo doxycycline. Subjects will complete a questionnaire, and will be given a simple standardized log in which they will be asked to keep track of adherence to the study drug, record solicited adverse events, note when symptoms disappear and/or reappear, and document sexual activity between study visits.

Subjects who test positive for M. genitalium or Ureaplasmas at the initial clinic
Sponsor: University of Washington

Current Primary Outcome:

  • mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit [ Time Frame: approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit) ]
    Microbiologic cure of M. genitalium at first follow-up visit (defined as a negative in-house PCR test performed on urine)
  • mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit [ Time Frame: 3 weeks (allowable window 2-5) ]
    Microbiologic cure, defined as negative PCR for U. urealyticum (if cultured), or negative culture at first follow-up visit


Original Primary Outcome:

Current Secondary Outcome:

  • Minimum Inhibitory Concentrations (MIC) of All Cultivable Strains of M. Genitalium and Ureaplasmas [ Time Frame: on-going ]
  • Clinical Cure as Measured by the Absence of Recurrent or Persistent Signs and/or Symptoms of Urethral Infection Among Case Subjects Who Were Positive for M. Genitalium or Ureaplasmas at the Initial Study Visit [ Time Frame: approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit) ]


Original Secondary Outcome:

Information By: University of Washington

Dates:
Date Received: July 27, 2006
Date Started: January 2007
Date Completion:
Last Updated: February 1, 2013
Last Verified: February 2013