Status:
COMPLETED
Efficacy of Combination Therapies for Gonorrhea Treatment
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Gonorrhoea
Eligibility:
All Genders
15-60 years
Phase:
PHASE4
Brief 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 gonorrhe...
Detailed Description
Infection with Neisseria (N.) gonorrhoeae carries a significant public health burden in the United States (U.S.). Gonococcal infection can result in pelvic inflammatory disease (PID), ectopic pregnanc...
Eligibility Criteria
Inclusion
- Male or female from 15 - 60 years old.
- Is either:
- 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.
- Urethral or cervical gram stain demonstrating gram negative intracellular diplococci and leukocytes.
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
614 Patients enrolled
Trial Details
Trial ID
NCT00926796
Start Date
June 1 2010
End Date
May 1 2013
Last Update
August 19 2015
Active Locations (5)
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1
University of Alabama Hospital - Infectious Diseases
Birmingham, Alabama, United States, 35249-0001
2
Los Angeles County Department of Public Health - Sexually Transmitted Disease Program
Los Angeles, California, United States, 90007-2608
3
San Francisco Department of Public Health - San Francisco City Clinic
San Francisco, California, United States, 94103-4030
4
Johns Hopkins Bayview Medical Center - Infectious Diseases
Baltimore, Maryland, United States, 21224-2735