Clinical Trial: Efficacy of Combination Therapies for Gonorrhea Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Clinical Trial Evaluating the Efficacy of Gentamicin/Azithromycin and Gemifloxacin/Azithromycin Combination Therapies as an Alternative Regimen for Uncomplicated Urogenital

  • Microbiological Efficacy of Gentamicin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection [ Time Frame: 10-17 days after treatment. ]
    Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure)
  • Microbiological Efficacy of Gemifloxacin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection [ Time Frame: 10-17 days after treatment. ]
    Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure)


    • Original Primary Outcome: Number of enrollees negative by culture at cervix/urethra, regardless of history of re-exposure, divided by the number of positive gonococcal culture at cervix/urethra at enrollment and who return within 10-17 days. [ Time Frame: 10-17 days after treatment. ]

    Current Secondary Outcome:

    • Eradication of Rectal Infection [ Time Frame: 10-17 days after treatment. ]
      Number of enrollees with positive rectal culture at enrollment who have negative culture 10-17 days after treatment
    • Eradication of Pharyngeal Infection [ Time Frame: 10-17 days after treatment. ]
      Number of enrollees with positive pharyngeal culture at enrollment who have negative culture 10-17 days after treatment
    • Antimicrobial Susceptibility Profile of Treatment Failures. [ Time Frame: Isolates obtained at enrollment (Day 0). ]
      For treatment failures (i.e., participants with positive culture at cervix/urethra 10-17 days after treatment), the minimum inhibitory concentrations for various antimicrobial agents (Azithromycin, Cefixime, Ceftriaxone, Ciprofloxacin, Gemifloxacin, Gentamicin, Penicillin, Tetracycline).
    • Clinical Profile of Treatment Failures. [ Time Frame: 10-17 days ]
      For treatment failures (i.e., participants with positive culture at cervix/urethra 10-17 days after treatment), number participants with clinical symptoms (vaginal/urethral discharge, dysuria, dyspareunia) at 10-17 days.
    • Resolution of Symptoms and Signs (Clinical Cure) [ Time Frame: 10-17 days after treatment. ]
      Number of participants whose gonorrhea-related symptoms (e.g. vaginal/urethral discharge, dysuria, dyspareunia) present at enrollment has resolved by visit 2.
    • Antimicrobial Susceptibility Profile of Enrollment Isolates. [ Time Frame: Isolates obtained at enrollment (Day 0). ]
      Minimum inhibitory concentration (micrograms/milliliter) of pretreatment gonorrhea isolates collected from participants
    • Number of Participants With Adverse Events for Each Regimen [ Time Frame: Day 0 through Day 30 ]
      Number of treated participants experiencing mild, moderate, severe, or life-threatening adverse events (AEs) either temporarily associated or not associated with study product.


    Original Secondary Outcome:

    • Resolution of symptoms and signs (clinical cure) assessed by the proportion of patients whose gonorrhea-related symptoms present at enrollment have resolved. [ Time Frame: 10-17 days after treatment. ]
    • Eradication of rectal or pharyngeal infection. [ Time Frame: 10-17 days after treatment. ]
    • Antimicrobial Susceptibility Profile of Enrollment Isolates. [ Time Frame: Isolates obtained at enrollment. ]
    • Clinical and antimicrobial susceptibility profile of treatment failures. [ Time Frame: Isolates obtained at a follow-up study visit after drug administration. Data obtained on all treatment failures. ]
    • Safety and tolerability of each regimen: percent of treated patients experiencing mild, moderate, severe, or life-threatening adverse events (AEs) either temporarily associated or not associated with study product. [ Time Frame: Duration of study. ]


    Information By: National Institute of Allergy and Infectious Diseases (NIAID)

    Dates:
    Date Received: June 23, 2009
    Date Started: June 2010
    Date Completion:
    Last Updated: July 23, 2015
    Last Verified: June 2013