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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Age ≥ 12 years old (if enrolment of minors is in agreement with local regulations and Ethics guidance)
Weight ≥ 35 kg
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)
For females of child-bearing potential, a negative urine pregnancy test at screening
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.
For males with a female partner of child-bearing age, willingness to delay conception for 28 days after treatment
Willingness to comply with trial protocol
Willingness to undergo HIV testing
Willingness to abstain from sexual intercourse or use condoms for vaginal, anal and oral sex until end of trial visit
Willingness and ability to give written informed consent or be consented by a legal representative or provide assent and parental consent (for minors, as appropriate).
Exclusion Criteria:
Confirmed or suspected complicated or disseminated gonorrhoea
Pregnant or breastfeeding women
Known concomitant infection which would require immediate additional systemic antibiotics with activity against NG (e.g. CT infection)
Use of any systemic or intravaginal antibiotics with activity against NG within 30 days prior to screening
Use of systemic corticoid drugs or other immunosuppressive therapy within 30 days prior to screening
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
Cytotoxic or radiation therapy within 30 days prior to screening
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
History of urogenital sex-reassignment surgery
Immunosuppression as evidenced by medical history, clinical examination or a recent (≤ 1 month) CD4 count <200 cells/μL
Know clinically relevant cardiac pro-arrhythmic conditions such as cardiac arrhythmia, congenital or documented QT prolongation
Known history of severe allergy to cephalosporin, penicillin, monobactams, carbapenems or macrolide antibiotics
Known or suspected allergies or hypersensitivities to lidocaine, methylparaben, lactose or any of the components of the study drugs (refer to the zoliflodacin IB and SmPC for the comparators treatments)
Receipt or planned receipt of an investigational product in a clinical trial within 30 days or five half-lives of the drug, whichever is greater, prior to screening until end of participation to this clinical trial
History of alcohol or drug abuse within 12 months prior to screening which would compromise trial participation in the judgment of the investigator
Severe medical or psychiatric condition which, in the opinion of the investigator, may increase the risk associated with trial participation or may interfere with the interpretation of trial results or affect the individual's ability to provide informed consent
Individuals whom, in the judgement of the investigator, are unlikely or unable to comply with this trial protocol
Previous randomisation in this clinical trial.
Use of moderate or strong CYP3A4 inhibitors within 30 days or five half-lives of the drug, whichever is greater, prior to screening
Primary purpose
Allocation
Interventional model
Masking
1,011 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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