NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)
Condition: Urethritis
MeSH terms: Urethritis
Intervention: Tinidazole; Placebo; Doxycycline; Azithromycin
Intervention description: 2 gm single dose (4 tablets orally at 500 mg each).; Placebo capsule will be filled with lactose only and be identical in appearance to the capsule of Azithromycin, Tinidazole, Doxycycline.; 100 mg orally, twice daily for 7 days.; 1 gram (gm) (2 tablets orally at 500 milligrams (mg) each).
Intervention MeSH terms: Azithromycin; Doxycycline; Tinidazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 305.0
Sex: Male
Minimum age: 16 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: non-gonococcal urethritis, doxycycline, azithromycin, sexually transmitted, tinidazole

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.