Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Melinta Therapeutics, Inc.
With
National Institute of Allergy and Infectious Diseases (NIAID)
Age
15–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
