NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)
Condition: Urethritis
MeSH terms: Urethritis
Study type: Interventional
Phase: Phase 2

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.
    

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 of cure rates between the 2 currently recommended therapies for NGU,
      doxycycline and azithromycin. Emerging clinical data has suggested that the latter may have
      become more efficacious for NGU as it is more effective in eradicating Mycoplasma (M.)
      genitalium from the genital tract than the former. Only in vitro data, limited as it is,
      suggests that doxycycline should be active against M. genitalium. The researchers hypothesize
      that cure rates for NGU will be significantly improved for both doxycycline and azithromycin
      using combination therapy with tinidazole. Important safety and tolerability data will be
      collected with regards to the use of combination therapy. Additionally, the study will
      provide data on the prevalence of the targeted pathogens in 4 geographic areas and on
      characteristics of men with NGU that may help to target populations who would benefit the
      most from combination therapy. The researchers hypothesize that currently recommended initial
      therapies for NGU are inadequate in at least certain populations due to lack of coverage for
      Trichomonas (T.) vaginalis. The researchers further hypothesize that between the 2 currently
      recommended regimens, azithromycin will result in a greater number of cures than doxycycline
      due to its greater efficacy in M. genitalium infected men. The primary study objectives are
      to: compare the clinical cure rates of doxycycline versus doxycycline with tinidazole; and
      azithromycin versus azithromycin with tinidazole for the treatment of NGU; and to evaluate
      the safety and tolerability of doxycycline/tinidazole and azithromycin/tinidazole in the
      treatment of NGU. Secondary study objectives are to: evaluate microbiological cure of
      Chlamydia (C.) trachomatis, T. vaginalis, M. genitalium in men treated with doxycycline
      versus doxycycline with tinidazole; and azithromycin versus azithromycin with tinidazole.
      Analysis will also include: (doxycycline plus doxycycline/tinidazole) versus (azithromycin
      plus azithromycin/tinidazole); for the clinical cure rates, analysis will also include:
      (doxycycline plus doxycycline/tinidazole) versus (azithromycin plus azithromycin/tinidazole);
      determine the prevalence of C. trachomatis, T. vaginalis, and M. genitalium in the study
      population of men with non-gonococcal urethritis; determine clinical, behavioral, and
      demographic predictors of the above organisms in men with non-gonococcal urethritis; and
      collect specimens for future studies to determine the role of unique and novel pathogens in
      the etiology of non-gonococcal urethritis. Outcome measures include clinical failure,
      clinical cure, microbiological cure, and unevaluable cure assessed at the first and second
      follow-up visits. Study participants will include 300 men ages 16-45 years with NGU attending
      sexually transmitted disease clinics in Birmingham, AL; New Orleans, LA; Durham, NC; and
      Baltimore, MD. Subjects will be randomly assigned to 1 of 4 active treatment arms: 75
      subjects doxycycline; 75 subjects doxycycline plus tinidazole; 75 subjects azithromycin; and
      75 subjects azithromycin plus tinidazole.
    

Intervention name(s): Tinidazole; Placebo; Doxycycline; Azithromycin
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: non-gonococcal urethritis, doxycycline, azithromycin, sexually transmitted, tinidazole