NCT02210325CompletedPhase 3
An Open-Label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Dose of Oral Solithromycin Compared to Single-Dose Intramuscular Ceftriaxone Plus Single-Dose Oral Azithromycin in the Treatment of Male and Female Patients With Uncomplicated Urogenital Gonorrhea With or Without Concomitant Chlamydia
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Melinta Therapeutics, Inc.
- Enrollment
- 264
- Primary Endpoint
- To assess the eradication rate of Neisseria gonorrhoeae by culture following a single dose of oral solithromycin compared to single-dose intramuscular ceftriaxone plus oral azithromycin in the Microbiological Intent to Treat population.
Study Overview
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 completed open-label Phase 2 study with single doses of solithromycin resulted in 100% microbiological eradication in male and female patients with uncomplicated urogenital gonorrhea.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Ceftriaxone plus Azithromycin
Active Comparator
A single intramuscular dose of 500 mg ceftriaxone plus a single oral dose of 1000 mg azithromycin
Intervention: ceftriaxone (Drug)
Ceftriaxone plus Azithromycin
Active Comparator
A single intramuscular dose of 500 mg ceftriaxone plus a single oral dose of 1000 mg azithromycin
Intervention: azithromycin (Drug)
Solithromycin
Experimental
A single oral dose of 1000 mg solithromycin
Intervention: solithromycin (Drug)
Outcomes
Primary Outcomes
To assess the eradication rate of Neisseria gonorrhoeae by culture following a single dose of oral solithromycin compared to single-dose intramuscular ceftriaxone plus oral azithromycin in the Microbiological Intent to Treat population.
Time Frame: 7 days after treatment
Secondary Outcomes
- To assess clearance or persistence of N. gonorrhoeae and Chlamydia trachomatis nucleic acid from male and female genital, pharyngeal and rectal specimens.(21 days after treatment)
- To assess the safety and tolerability of a single oral dose of solithromycin compared to single-dose IM ceftriaxone plus single-dose oral azithromycin in patients with gonorrhea(7 days)
- To compare bacterial eradication rates of N. gonorrhoeae from rectal or pharyngeal cultures following a single dose of oral solithromycin compared to single-dose IM ceftriaxone plus oral azithromycin.(7 days)
Investigators
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