Zoliflodacin in Uncomplicated Gonorrhoea

Inclusion Criteria:

1. Age ≥ 12 years old (if enrolment of minors is in agreement with local regulationsand Ethics guidance)

2. Weight ≥ 35 kg

3. Signs and symptoms consistent with urethral or cervical gonorrhoea OR Urethral orcervical uncomplicated gonorrhoea as determined by either a positive culture or NAATor Gram stain or methylene blue test/gentian violet stain in the past 14 days priorto screening OR Unprotected sexual contact with an individual reported to beinfected with NG in the past 14 days prior to screening (confirmation by a positiveNAAT, Gram stain or methylene blue test/ gentian violet stain or culture)

4. For females of child-bearing potential, a negative urine pregnancy test at screening

5. For females of child bearing potential, use of highly effective contraception for atleast 28 days prior to screening and during at least 28 days after treatment.Females on oral contraceptives must also use a barrier contraception method duringparticipation in the study.

6. For males with a female partner of child-bearing age, willingness to delayconception for 28 days after treatment

7. Willingness to comply with trial protocol

8. Willingness to undergo HIV testing

9. Willingness to abstain from sexual intercourse or use condoms for vaginal, anal andoral sex until end of trial visit

10. Willingness and ability to give written informed consent or be consented by a legalrepresentative or provide assent and parental consent (for minors, as appropriate).

Exclusion Criteria:

11. Confirmed or suspected complicated or disseminated gonorrhoea

12. Pregnant or breastfeeding women

13. Known concomitant infection which would require immediate additional systemicantibiotics with activity against NG (e.g. CT infection)

14. Use of any systemic or intravaginal antibiotics with activity against NG within 30days prior to screening

15. Use of systemic corticoid drugs or other immunosuppressive therapy within 30 daysprior to screening

16. 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

17. Cytotoxic or radiation therapy within 30 days prior to screening

18. Known chronic renal, hepatic, hematologic impairment or other condition interferingwith the absorption, distribution or elimination of the drug based on medicalhistory and physical examination

19. History of urogenital sex-reassignment surgery

20. Immunosuppression as evidenced by medical history, clinical examination or a recent (≤ 1 month) CD4 count <200 cells/μL

21. Know clinically relevant cardiac pro-arrhythmic conditions such as cardiacarrhythmia, congenital or documented QT prolongation

22. Known history of severe allergy to cephalosporin, penicillin, monobactams,carbapenems or macrolide antibiotics

23. Known or suspected allergies or hypersensitivities to lidocaine, methylparaben,lactose or any of the components of the study drugs (refer to the zoliflodacin IBand SmPC for the comparators treatments)

24. 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 screeninguntil end of participation to this clinical trial

25. History of alcohol or drug abuse within 12 months prior to screening which wouldcompromise trial participation in the judgment of the investigator

26. Severe medical or psychiatric condition which, in the opinion of the investigator,may increase the risk associated with trial participation or may interfere with theinterpretation of trial results or affect the individual's ability to provideinformed consent

27. Individuals whom, in the judgement of the investigator, are unlikely or unable tocomply with this trial protocol

28. Previous randomisation in this clinical trial.

29. Use of moderate or strong CYP3A4 inhibitors within 30 days or five half-lives of thedrug, whichever is greater, prior to screening