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Phase 1

• Conditions: ncomplicated gonorrhoea; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-000990-22-BE
• Lead Sponsor: GARDP FOUNDATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-06
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 1092

Inclusion Criteria

1. = 12 years old (if enrolment of minors is in agreement with local regulations and ethics guidance)
2. = 35 kilogram (kg)
3. 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/gentian violet stain in the past 14 days prior to screening
OR
Unprotected sexual contact with an individual confirmed to be infected with N. gonorrhoeae in the past 14 days prior to screening (positive NAAT, Gram stain, methylene blue/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 (see Appendix 1) from at least 28 days prior to screening and until at least 28 days after
treatment. Females on oral contraceptives must also use a barrier contraception method during participation in the study
6. For males with a female partner of child-bearing age, willingness to delay conception during the trial and 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 and oral sex from enrolment until end of trial visit
10. 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)
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 992
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

11. Confirmed or suspected complicated or disseminated gonorrhoea
12. Pregnant or breastfeeding females
13. Known concomitant infection which would require immediate additional systemic antibiotics with activity against NG (e.g. CT infection)
14. Use of any systemic or intravaginal antibiotics with activity against NG within 30 days prior to screening
15. Use of systemic corticoid drugs or other immunosuppressive therapy within 30 days prior 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 interfering with the absorption, distribution or elimination of the drug, based on medical
history and physical examination
19. History of urogenital sex-reassignment surgery
20. Immunosuppression as evidence by medical history, clinical examination or a recent (=1 month) CD4 count below 200 cells/microliter (µL)
21. Known clinically relevant cardiac pro-arrhythmic conditions such as cardiac arrhythmia, 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 investigator brochure (IB) and summaries of product characteristics (SmPC) for the comparator 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 screening until end of participation to this clinical trial
25. History of alcohol or drug abuse in the 12 months prior to screening which would compromise trial participation in the judgement of the investigator
26. Severe medical or psychiatric condition that, 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
27. Individuals whom, in the judgement of the investigator, are unlikely or unable to comply 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 the drug, whichever is greater, prior to screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified