Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea (SOLITAIRE-U)

Melinta Therapeutics

Status and phase: Completed; Phase 3

Conditions: Uncomplicated Urogenital Gonorrhea

Treatments: Drug: azithromycin; Drug: ceftriaxone; Drug: solithromycin

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT02210325

CE01-302

15-0091, HHSN272201300013 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 264 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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264 participants in 2 patient groups

Ceftriaxone plus Azithromycin

Active Comparator group

Description:

A single intramuscular dose of 500 mg ceftriaxone plus a single oral dose of 1000 mg azithromycin

Treatment:

Drug: ceftriaxone

Drug: azithromycin

Solithromycin

Experimental group

Description:

A single oral dose of 1000 mg solithromycin

Treatment:

Drug: solithromycin