Status:
COMPLETED
Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Urethritis
Eligibility:
MALE
16+ years
Phase:
PHASE3
Brief 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 inclu...
Detailed Description
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 nongonoco...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
606 Patients enrolled
Trial Details
Trial ID
NCT00358462
Start Date
January 1 2007
End Date
November 1 2011
Last Update
August 15 2018
Active Locations (1)
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1
Public Health -- Seattle & King County Sexually Transmitted Diseases Clinic located at Harborview Medical Center
Seattle, Washington, United States, 98104