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Phase 3 N=606 Randomized Quadruple-blind Treatment

Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)

Urethritis

Enrolled (actual)
606
Serious AEs
0.7%
Results posted
Mar 2013
Primary outcome: Primary: mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit — 15; 8 participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Azithromycin (Drug); Doxycycline (Drug)
Age
Pediatric, Adult, Older Adult · 16+ yrs
Sex
Male
Sponsor
University of Washington
Primary completion
Nov 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit
15; 8
PRIMARY
mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit
39; 38
SECONDARY
Clinical Cure Among Case Subjects Who Were Positive for M. Genitalium at the Initial Study Visit
24; 13
SECONDARY
Clinical Cure Among Case Subjects Who Were Positive for Ureaplasmas at the Initial Study Visit
43; 40
SECONDARY
Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Azithromycin
31; 25
SECONDARY
Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Doxycycline
0.5
SECONDARY
Minimum Inhibitory Concentrations (MIC) of U. Ureaplasma Biovar 2
1.00; 0.5; 0.5
SECONDARY
Minimum Inhibitory Concentrations (MIC) of U. Parvum
0.5; 0.25; 0.25

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00358462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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