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

Cempra Pharmaceuticals, Inc.0 sites300 target enrollmentOctober 10, 2014

Overview

No summary available.

Registry

who.int

Start Date

October 10, 2014

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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.