Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital Gonorrhea
Completed · Phase 2
Conditions studied: Uncomplicated Urogenital Gonorrhea
In brief
To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the treatment of uncomplicated urogenital gonorrhea.
Key facts
- Study ID
- NCT01591447
- Run by
- Melinta Therapeutics, Inc.
- People needed
- 60
- Starts
- 2012-05-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2017-03-03
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Evidence of a urogenital gonococcal infection (prior culture, NAAT test, Gram stain, sexual contact)
- Willing to abstain from anal, oral, or vaginal sexual intercourse or use condoms 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 qualify if…
- Confirmed, or suspected, complicated or systemic gonococcal infections such as pelvic inflammatory disease, arthritis, or endocarditis.
- Known HIV, chronic hepatitis B, or hepatitis C infection.
- Known concomitant infection which would require additional systemic antibiotics.
- Use of systemic or intravaginal antibiotics within 30 days prior to study drug administration.
- Current use of corticosteroid drugs or other immunosuppressive therapy.
- Cytotoxic chemotherapy or radiation therapy within the previous 3 months.
- Known significant renal, hepatic, or hematologic impairment.
- History of intolerance or hypersensitivity to macrolide antibiotics.
- Any concomitant condition that, in the opinion of the Investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy and follow-up could be completed (e.g., life expectancy <30 days).
Where it is running
- Jefferson County Department of Health — Birmingham, Alabama, United States
- Harborview STD Clinic — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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