NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)
Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)