Efficacy and safety of solithromycin in patients with gonorrhea.

• Conditions: gonorrhoea; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-004040-36-Outside-EU/EEA
• Lead Sponsor: Cempra Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-10
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1) 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.
2) The patient must be willing to abstain from anal, oral, and vaginal sexual intercourse or use condoms for all of these until study completion.
3) Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment.

Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Confirmed or suspected complicated or systemic gonococcal infections such as pelvic inflammatory disease, epididymitis, arthritis, endocarditis, or disseminated gonococcal infection.
2) Individuals who have already received antibiotic treatment for their gonorrhea.
3) Use of systemic or intravaginal antibiotics within 7 days prior to study drug administration.
4) Women who are pregnant or nursing.
5) Men with suspected or confirmed rectal gonorrhea and symptoms of proctitis.
6) History of significant intolerance or allergy to macrolide or cephalosporin antibiotics.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified