Efficacy of Combination Therapies for Gonorrhea Treatment
Condition: Gonorrhoea
MeSH terms: Gonorrhea
Intervention: Azithromycin; Gentamicin; Gemifloxacin
Intervention description: Four 500 mg tablets will be administered orally to equal a 2 gm dose.; Fixed dose of 240 mg intramuscular one time for patients >45 kg and a 5 mg/kg dose for patients less than or equal to 45 kg based on their measured weight in clinic. Most patients will require 2 injections of gentamicin in separate large muscle groups.; One 320 mg tablet administered orally.
Intervention MeSH terms: Azithromycin; Gentamicins; Gemifloxacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 614.0
Sex: All
Minimum age: 15 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: gonorrhea, gonococcal infections, Neisseria gonorrhoeae

Summary:

      The purpose of this study is to learn how to better treat gonorrhea infections. Gonorrhea is
      a sexually transmitted disease (STD) that is usually cured with a single antibiotic. However,
      some gonorrhea is not cured with a single antibiotic. The study will look at how well
      treating gonorrhea with 2 antibiotics works. Participants will be assigned to 1 of 2
      treatment groups each receiving a combination of 2 antibiotics. Sites in the United States
      will recruit 500 male and female participants. Participants must be 15 to 60 years old, in
      good health and identified in participating sexually transmitted disease clinics as having
      uncomplicated cervical or urethral gonorrhea. Procedures include collection of current
      symptoms, medical and sexual history, sexual orientation, vital signs, height, weight,
      cervical/urethral cultures and clinical examinations. Volunteers will be involved for about
      17 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female from 15 - 60 years old.

          -  Is either:

               1. Untreated male or female with urethral or cervical gonorrhea as determined by a
                  screening laboratory test [either Nucleic Acid Amplification Test (NAAT) or
                  culture] for Neisseria gonorrhoeae at a prior visit.

               2. Urethral or cervical gram stain demonstrating gram negative intracellular
                  diplococci and leukocytes.

               3. Untreated male or female who is a sexual contact (anal, oral, or vaginal) of an
                  individual with gonorrhea in the past 60 days.

          -  Willing to abstain from anal, oral, or vaginal sexual intercourse or use condoms until
             follow up is completed.

          -  Willing to follow up from 10 to 17 days following enrollment.

          -  Willing to provide written consent.

          -  Able to swallow pills.

        Exclusion Criteria:

          -  Known renal insufficiency from clinical history

          -  Known hepatic insufficiency from clinical history

          -  Known QT interval prolongation from clinical history

          -  Known neuromuscular disorder from clinical history (i.e., myasthenia gravis or
             Parkinson's disease)

          -  Known rheumatoid arthritis or tendon disorders from clinical history

          -  Known kidney, heart, or lung transplants from clinical history

          -  Pregnant women (determined by positive urine pregnancy test)

          -  Breastfeeding women

          -  Known allergy or adverse reaction to macrolides, aminoglycosides, or quinolones

          -  Concomitant infection (besides chlamydia or bacterial vaginosis) which requires
             systemic antibiotics

          -  Has received systemic or intravaginal antibiotics within 30 days of study enrollment

          -  Currently taking corticosteroid drugs or other immunosuppressive therapy

          -  Currently taking cardiac antiarrhythmia drugs

          -  Self report of or clinical diagnosis of abdominal pain, pelvic inflammatory disease
             (PID), testicular pain, epididymitis, or disseminated gonococcal infection

          -  Self report of or clinical diagnosis of current genital ulcer (GU)

          -  In the judgment of the interviewer, has a medical condition or other factor that might
             affect their ability to follow the protocol

          -  Previous enrollment in this study