Efficacy of Combination Therapies for Gonorrhea Treatment
Randomized Clinical Trial Evaluating the Efficacy of Gentamicin/Azithromycin and Gemifloxacin/Azithromycin Combination Therapies as an Alternative Regimen for Uncomplicated Urogenital Gonorrhea
1 other identifier
interventional
614
1 country
5
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2010
Typical duration for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2009
CompletedFirst Posted
Study publicly available on registry
June 24, 2009
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
March 20, 2014
CompletedAugust 19, 2015
June 1, 2013
2.5 years
June 23, 2009
November 25, 2013
July 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Microbiological Efficacy of Gentamicin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection
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)
10-17 days after treatment.
Microbiological Efficacy of Gemifloxacin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection
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)
10-17 days after treatment.
Secondary Outcomes (7)
Eradication of Rectal Infection
10-17 days after treatment.
Eradication of Pharyngeal Infection
10-17 days after treatment.
Antimicrobial Susceptibility Profile of Treatment Failures.
Isolates obtained at enrollment (Day 0).
Clinical Profile of Treatment Failures.
10-17 days
Resolution of Symptoms and Signs (Clinical Cure)
10-17 days after treatment.
- +2 more secondary outcomes
Study Arms (2)
Regimen B: gemifloxacin plus azithromycin
EXPERIMENTALGemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
Regimen A: gentamicin plus azithromycin
EXPERIMENTALGentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of Alabama Hospital - Infectious Diseases
Birmingham, Alabama, 35249-0001, United States
Los Angeles County Department of Public Health - Sexually Transmitted Disease Program
Los Angeles, California, 90007-2608, United States
San Francisco Department of Public Health - San Francisco City Clinic
San Francisco, California, 94103-4030, United States
Johns Hopkins Bayview Medical Center - Infectious Diseases
Baltimore, Maryland, 21224-2735, United States
Magee Women's Hospital of UPMC - Reproductive Infectious Disease Research
Pittsburgh, Pennsylvania, 15213-3108, United States
Related Publications (1)
Kirkcaldy RD, Weinstock HS, Moore PC, Philip SS, Wiesenfeld HC, Papp JR, Kerndt PR, Johnson S, Ghanem KG, Hook EW 3rd. The efficacy and safety of gentamicin plus azithromycin and gemifloxacin plus azithromycin as treatment of uncomplicated gonorrhea. Clin Infect Dis. 2014 Oct 15;59(8):1083-91. doi: 10.1093/cid/ciu521. Epub 2014 Jul 16.
PMID: 25031289RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
After the SMC meeting held during August 2012, the SMC recommended halting trial enrollment because continued participant accrual to targeted enrollment of 500 infected participants would be highly unlikely to alter the results.
Results Point of Contact
- Title
- Shelly Lensing
- Organization
- University of Arkansas for Medical Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2009
First Posted
June 24, 2009
Study Start
June 1, 2010
Primary Completion
December 1, 2012
Study Completion
May 1, 2013
Last Updated
August 19, 2015
Results First Posted
March 20, 2014
Record last verified: 2013-06