Status:
COMPLETED
Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea
Lead Sponsor:
Melinta Therapeutics, Inc.
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Uncomplicated Urogenital Gonorrhea
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
This study will compare a single dose of oral solithromycin to the standard of care (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with urogenital gonorrhea. A complet...
Eligibility Criteria
Inclusion
- At least 1 of the following:
- Untreated male with urethral gonorrhea as determined by a screening laboratory test (either NAAT or culture) for N. gonorrhoeae within 2 weeks prior to study drug administration.
- Untreated female with cervical gonorrhea as determined by a screening laboratory test (either NAAT or culture) for N. gonorrhoeae within 2 weeks prior to study drug administration.
- Urethral (male) or cervical (female) Gram stain demonstrating Gram-negative intracellular diplococci and leukocytes.
- The patient must be willing to abstain from anal, oral, and vaginal sexual intercourse or use condoms for all of these until study completion.
- Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment.
Exclusion
- Confirmed or suspected complicated or systemic gonococcal infections such as pelvic inflammatory disease, epididymitis, arthritis, endocarditis, or disseminated gonococcal infection.
- Individuals who have already received antibiotic treatment for their gonorrhea.
- Use of systemic or intravaginal antibiotics within 7 days prior to study drug administration.
- Women who are pregnant or nursing.
- Men with suspected or confirmed rectal gonorrhea and symptoms of proctitis.
- History of significant intolerance or allergy to macrolide or cephalosporin antibiotics.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2017
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT02210325
Start Date
August 1 2014
End Date
February 22 2017
Last Update
September 11 2017
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Baltimore, Maryland, United States, 21205
2
Cleveland, Ohio, United States, 44109
3
Toledo, Ohio, United States, 43614
4
Sydney, New South Wales, Australia, 2000