A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea

  • End date
    Oct 31, 2023
  • participants needed
  • sponsor
Updated on 11 April 2023
neisseria gonorrhoeae


This is a phase III, randomized, multicenter, open-label study which will be performed to evaluate efficacy and safety of oral Gepotidacin compared to intramuscular (IM) ceftriaxone plus oral azithromycin for the treatment of uncomplicated urogenital infection caused by Neisseria gonorrhoeae (N. gonorrhoeae) in adolescent and adult participants. In this study, participants will be randomly assigned to receive either oral gepotidacin or IM ceftriaxone plus oral azithromycin.

Condition Gonorrhea
Treatment Azithromycin, ceftriaxone, Gepotidacin
Clinical Study IdentifierNCT04010539
Last Modified on11 April 2023


Yes No Not Sure

Inclusion Criteria

Participants must be >=12 years of age at the time of signing the informed consent
Participants having body weight of >45 kilogram (kg)
Participants having clinical suspicion of a urogenital gonococcal infection with or without pharyngeal and/or rectal gonococcal infection and have one of the following: male participants with purulent yellow, green, or white urethral discharge or female participants with abnormal cervical or vaginal mucopurulent discharge upon physical examination; or a prior positive culture for N. gonorrhoeae from up to 5 days before screening (as long as the participant has not received any treatment for this infection); or a Gram or equivalent stain (urogenital specimens only) positive or presumptive for Gram-negative intracellular diplococci from up to 5 days before screening (as long as the participant has not received any treatment for this infection); or a prior positive nucleic acid amplification test assay for N. gonorrhoeae from up to 7 days before screening (as long as the participant has not received any treatment for this infection)
Participants who are willing to avoid anal, oral, and vaginal sexual intercourse or use condoms for all forms of intercourse from the Baseline Visit through the TOC Visit
Male or female participants having his or her original urogenital anatomy at birth
Male participant must agree to use contraception (male condoms) during intercourse from the Baseline Visit through completion of the TOC Visit
Female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance (male partners of WOCBP must use a male condom during intercourse) from the Baseline Visit through completion of the TOC Visit
Participants who are capable of giving signed informed consent or assent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) or assent form and in study protocol

Exclusion Criteria

Male participants with a current diagnosis of epididymitis and/or orchitis at the time of the Baseline Visit
Participant who is suspected or confirmed to have a Chlamydia trachomatis infection and per the investigator's judgement standard-of-care treatment for this infection cannot be safely postponed until the TOC Visit
Participant has a body mass index >=40 kilogram per square meter (kg/m^2) or has a body mass index >=35.0 kg/m^2 and is experiencing obesity-related health conditions such as high blood pressure or diabetes
Participant has a history of sensitivity to the study treatments, or components thereof, or a history of a drug (including erythromycin and any macrolide or ketolide drug) or other allergy that, in the opinion of the investigator or medical monitor, contraindicates his or her participation
Participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications
Participants with a known cluster of differentiation 4 (CD4) count of <200 cells per cubic millimeter (cells/mm^3)
Participant has any of the following: poorly controlled asthma or chronic obstructive pulmonary disease, acute severe pain, uncontrolled with conventional medical management, active peptic ulcer disease, Parkinson disease, Myasthenia gravis, a history of seizure disorder requiring medications for control or participant has any surgical or medical condition that may interfere with drug absorption, distribution, metabolism, or excretion of the study treatment
Participant has known anuria, oliguria, or severe impairment of renal function (creatinine clearance <30 milliliter per minute [mL/min] or clinically significant elevated serum creatinine as determined by the investigator)
Participant in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up
Participant has a serious underlying disease that could be imminently life threatening, or the participant is unlikely to survive for the duration of the study period
Participant has congenital long QT syndrome or known prolongation of corrected QT interval (QTc)
Participant has uncompensated heart failure
Participant has severe left ventricular hypertrophy
Participant has a family history of QT prolongation or sudden death
Participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or bradyarrhythmia within the last 12 months
The participant is taking QT-prolonging drugs or drugs known to increase the risk of torsades de pointes (TdP) per the [www.crediblemeds.org](http://www.crediblemeds.org/) "Known Risk of TdP" category at the time of his or her Baseline Visit, which cannot be safely discontinued from the Baseline Visit to the TOC Visit; or the participant is taking a strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor or a strong P-glycoprotein (P-gp) inhibitor
For any participant >=12 to <18 years, the participant has an abnormal electrocardiogram (ECG) reading
The participant has a QTc >450 millisecond (msec) or a QTc >480 msec for participants with bundle-branch block
Participant has a documented or recent history of uncorrected hypokalemia within the past 3 months
Participant has a known history of cholestatic jaundice or hepatic dysfunction associated with prior use of azithromycin
Participant has a known alanine aminotransferase (ALT) value >2 times upper limit of normal (ULN)
Participant has a known bilirubin value >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
Participant has a current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), including symptomatic viral hepatitis or moderate-to-severe liver insufficiency (Child Pugh class B or C)
Participant has been previously randomized in this study or has previously been treated with Gepotidacin
Participant has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives, whichever is longer
Participant has any of the following gonococcal infections that require a different dose or duration of treatment: suspected or confirmed pelvic inflammatory disease; or suspected or confirmed gonococcal arthritis; or suspected or confirmed gonococcal conjunctivitis; or suspected or confirmed gonococcal endocarditis; or other evidence of disseminated gonococcal infection
Participant has received any antibacterial therapy for the treatment of a gonococcal infection within 14 days before the Baseline Visit
Participant has received any systemic, topical, or intravaginal antibiotics or any systemic antifungals within 7 days before the Baseline Visit
Participant must not use St John's wort or ergot derivatives from within 14 days before the Baseline Visit through the TOC Visit
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