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NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Summary
This study will look at the safety, effectiveness, and tolerability of combination medications for the initial treatment of non-gonococcal urethritis (NGU). NGU is inflammation of the tube that carries urine from the bladder. NGU is caused by bacteria that may be passed from person to person during sex. This study will compare the 2 currently recommended NGU treatments, doxycycline and azithromycin, taken with tinidazole (another medication to treat certain sexually transmitted infections). Tinidazole used with doxycycline or azithromycin may cure NGU better than when doxycycline or azithromycin is used alone. Study participants will be 300 men ages 16-45 years with NGU attending sexually transmitted disease clinics in Birmingham, AL; New Orleans, LA; Durham, NC; and Baltimore, MD. Study participation will last 7 weeks and involve 3 visits. At each visit, participants will provide a urine sample, have 2 urethral swabs, and have their urethra checked for discharge indicating infection.
Official title: Phase II Randomized, Placebo-Controlled Double-Blind 4-Arm Trial for the Treatment of Non-Gonococcal Urethritis (NGU): Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)
Key Details
Gender
MALE
Age Range
16 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
305
Start Date
2006-11-17
Completion Date
2009-04-20
Last Updated
2026-08-27
Healthy Volunteers
No
Conditions
Interventions
Doxycycline
100 mg orally, twice daily for 7 days.
Placebo
Placebo capsule will be filled with lactose only and be identical in appearance to the capsule of Azithromycin, Tinidazole, Doxycycline.
Tinidazole
2 gm single dose (4 tablets orally at 500 mg each).
Azithromycin
1 gram (gm) (2 tablets orally at 500 milligrams (mg) each)
Locations (4)
University of Alabama Hospital - Infectious Diseases
Birmingham, Alabama, United States
Delgado Personal Health Center
New Orleans, Louisiana, United States
Johns Hopkins Hospital - Emergency Department
Baltimore, Maryland, United States
University of North Carolina School of Medicine - Center for Infectious Diseases
Chapel Hill, North Carolina, United States