Status:
COMPLETED
NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Urethritis
Eligibility:
MALE
16-45 years
Phase:
PHASE2
Brief 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 carrie...
Detailed Description
This study represents a clinical evaluation of the use of combination therapy for the initial treatment of non-gonococcal urethritis (NGU). This study will provide more current data on the comparison ...
Eligibility Criteria
Inclusion
- Male, 16 to 45 years old.
- Symptoms of non-gonococcal urethritis (NGU), including urethral discharge and/or dysuria for less than or equal to 14 days, or urethral discharge on exam.
- Urethral smear with greater than or equal to 5 polymorphonuclear leukocytes (PMNs) per 3-5 oil immersion fields.
- Willing to abstain from sexual intercourse or use condoms during the study.
- Willingness to provide written consent.
Exclusion
- Presence of gonorrhea at baseline visit.
- History of recurrent non-gonococcal urethritis (NGU) (3 or more episodes in the prior year) or history of recent NGU (within past 30 days).
- Signs or symptoms of epididymitis or prostatitis.
- Known allergy to or intolerance of tinidazole, tetracyclines, macrolides or metronidazole.
- History of photosensitivity related to doxycycline use.
- Received systemic antibiotics within 30 days of study enrollment.
- Unwillingness to abstain from alcohol for 24 hours after enrollment.
- Serious underlying infection, including known HIV or other primary or secondary immunosuppression.
- Concomitant infection, which requires antimicrobial therapy.
- History of mental illness, which would preclude responsible participation in the study.
- Current drug abuse that might affect ability to follow the protocol.
- Previously enrolled in this study.
- Men who have sex with men, due to different microbiology of NGU.
- Voided within the previous hour.
- Ingested alcohol within the past 8 hours.
- Subject requires concurrent lithium, anticoagulation therapy, or antabuse.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT00322465
Start Date
November 1 2006
End Date
April 1 2009
Last Update
March 1 2019
Active Locations (4)
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1
University of Alabama Hospital - Infectious Diseases
Birmingham, Alabama, United States, 35249-0001
2
Delgado Personal Health Center
New Orleans, Louisiana, United States, 70112-3503
3
Johns Hopkins Hospital - Emergency Medicine
Baltimore, Maryland, United States, 21287-0005
4
University of North Carolina School of Medicine - Center for Infectious Diseases
Chapel Hill, North Carolina, United States, 27599-7030