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NCT00358462 · ClinicalTrials.gov registry record · Phase 3
Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)
A Phase 3 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 3
- Development phase
- 606
- Enrollment target
NCT00358462 is a Phase 3 study that has completed, run by University of Washington. The registered enrollment target is 606 participants.
The verdict
NCT00358462, a Phase 3 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 606 participants
- Enrollment target
Study 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
Interventions
- DRUG Azithromycin
- DRUG Doxycycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 606 participants |
| Start Date | 2007-01 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00358462
The ClinicalTrials.gov registry entry for NCT00358462 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 606 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Azithromycin is the first listed.
NCT00358462 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00358462 about?
NCT00358462 is a clinical study titled "Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)". 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 clini...
What is the current status of trial NCT00358462?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 606 participants. The study started on 2007-01. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00358462?
The interventions under investigation include: Azithromycin (DRUG), Doxycycline (DRUG).
Who is sponsoring clinical trial NCT00358462?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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