Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)
Condition: Urethritis
MeSH terms: Urethritis
Intervention: Azithromycin; Doxycycline
Intervention description: two 500mg tablets or four 250mg tablets administered as a single dose; one 100mg capsule administered twice daily for seven days
Intervention MeSH terms: Azithromycin; Doxycycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 606.0
Sex: Male
Minimum age: 16 Years
Healthy volunteers: No
Keywords: NGU, M genitalium, Ureaplasma, azithromycin, doxycycline

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 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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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