Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea

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

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.

Inclusion Criteria:

• At least 1 of the following:

  1. 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.
  2. 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.
  3. 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.