CompletedPhase 2

Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital Gonorrhea

United States60 participantsStarted 2012-05

Plain-language summary

To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the treatment of uncomplicated urogenital gonorrhea.

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

The bacterial eradication rate, as measured by conversion from positive Neisseria gonorrhoeae baseline urethral or cervical culture to negative

Timeframe: 3 to 9 days after study drug dosing

NCT IDNCT01591447

SponsorMelinta Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-06

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.