Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)

• 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) ] [ Designated as safety issue: No ]
  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) ] [ Designated as safety issue: No ]
  Microbiologic cure, defined as negative PCR for U. urealyticum (if cultured), or negative culture at first follow-up visit
  
  

• Minimum Inhibitory Concentrations (MIC) of All Cultivable Strains of M. Genitalium and Ureaplasmas [ Time Frame: on-going ] [ Designated as safety issue: No ]
  
• 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) ] [ Designated as safety issue: No ]
  

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 visit will be asked to return for at least two follow-up study visits: at approximately 3 and 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 and re-tested for M. genitalium and Ureaplasmas. Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visits will receive a blinded treatment packet containing the alternate medication, or will be offered open-label moxifloxacin if the alternate treatment regimen was administered at the prior follow-up study visit. If additional treatment is administered at the 6-week follow-up study visit, a fourth study visit will be scheduled to occur approximately 9 or 10 weeks following the initial clinic visit.

Study participants who were negative for M. genitalium and Ureaplasma at enrollment will be asked to return for evaluation for a single follow-up study visit, approximately 3 weeks after the initial clinic visit. At this visit they will complete the follow-up questionnaire and provide specimens for future testing.