Zoliflodacin in Uncomplicated Gonorrhoea

  • End date
    Jul 31, 2023
  • participants needed
  • sponsor
    Global Antibiotics Research and Development Partnership
Updated on 21 February 2022
hiv testing
nucleic acid amplification test


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.

Condition Gonorrhea
Treatment Azithromycin, ceftriaxone, Zoliflodacin
Clinical Study IdentifierNCT03959527
SponsorGlobal Antibiotics Research and Development Partnership
Last Modified on21 February 2022


Yes No Not Sure

Inclusion Criteria

Age 12 years old (if enrolment of minors is in agreement with local regulations and thics 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
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/L
\. 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
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