Zoliflodacin in Uncomplicated Gonorrhoea (NCT03959527) | Clinical Trial Compass
CompletedPhase 3
Zoliflodacin in Uncomplicated Gonorrhoea
United States1,011 participantsStarted 2019-11-06
Plain-language summary
This trial is a multi-center, open label, randomized controlled, non-inferiority phase III trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin compared to a combination of a single intra-muscular 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment of uncomplicated gonorrhoea.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
ā. Age ā„ 12 years old (if enrolment of minors is in agreement with local regulations and Ethics guidance)
ā. Weight ā„ 35 kg
ā. Signs and symptoms consistent with urethral or cervical gonorrhoea OR Urethral or cervical uncomplicated gonorrhoea as determined by either a positive culture or NAAT or Gram stain or methylene blue test/gentian violet stain in the past 14 days prior to screening OR Unprotected sexual contact with an individual reported to be infected with NG in the past 14 days prior to screening (confirmation by a positive NAAT, Gram stain or methylene blue test/ gentian violet stain or culture)
ā. For females of child-bearing potential, a negative urine pregnancy test at screening
ā. For females of child bearing potential, use of highly effective contraception for at least 28 days prior to screening and during at least 28 days after treatment. Females on oral contraceptives must also use a barrier contraception method during participation in the study.
ā. For males with a female partner of child-bearing age, willingness to delay conception for 28 days after treatment
ā. Willingness to comply with trial protocol
ā. Willingness to undergo HIV testing
Exclusion criteria
ā1. Confirmed or suspected complicated or disseminated gonorrhoea
ā2. Pregnant or breastfeeding women
ā
What they're measuring
1
Microbiological Cure Rate for Zoliflodacin Compared to a Combination of a Single Dose of Ceftriaxone and Azithromycin.
Timeframe: Day 6 (+/- 2)
Trial details
NCT IDNCT03959527
SponsorGlobal Antibiotics Research and Development Partnership
3. Known concomitant infection which would require immediate additional systemic antibiotics with activity against NG (e.g. CT infection)
ā4. Use of any systemic or intravaginal antibiotics with activity against NG within 30 days prior to screening
ā5. Use of systemic corticoid drugs or other immunosuppressive therapy within 30 days prior to screening
ā6. Use of moderate or strong CYP3A4 inducers (e.g. efavirenz, rifampicin, carbamazepine, phenobarbital) within 30 days or five half-lives of the drug, whichever is greater, prior to screening
ā7. Cytotoxic or radiation therapy within 30 days prior to screening
ā8. Known chronic renal, hepatic, hematologic impairment or other condition interfering with the absorption, distribution or elimination of the drug based on medical history and physical examination