Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)
Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 3
Details
Lead Sponsor:
University of Washington
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)