Efficacy of Combination Therapies for Gonorrhea Treatment

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Azithromycin; Fluoroquinolones; Gemifloxacin; Gentamicins

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