Zoliflodacin in Uncomplicated Gonorrhoea

NCT ID: NCT03959527

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1011 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-06
• Study Completion Date: 2023-09-18

Brief Summary

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.

Conditions

Gonorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

zoliflodacin

Participant in this arm will receive a single dose of zoliflodacin.

Group Type: EXPERIMENTAL

zoliflodacin

Intervention Type: DRUG

Dose: 3g, oral administration

ceftriaxone and azithromycin combination

Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).

Group Type: ACTIVE_COMPARATOR

ceftriaxone

Intervention Type: DRUG

Dose: 500mg, Intra-Muscular (IM) administration

azithromycin

Intervention Type: DRUG

Dose: 1g, oral administration

Interventions

zoliflodacin

Dose: 3g, oral administration

Intervention Type: DRUG

ceftriaxone

Dose: 500mg, Intra-Muscular (IM) administration

Intervention Type: DRUG

azithromycin

Dose: 1g, oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

2. Weight ≥ 35 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 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)

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 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.

6. For males with a female partner of child-bearing age, willingness to delay conception 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 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).

Exclusion Criteria

11. Confirmed or suspected complicated or disseminated gonorrhoea

12. Pregnant or breastfeeding women

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 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 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 IB and 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 screening until end of participation to this clinical trial

25. History of alcohol or drug abuse within 12 months prior to screening which would compromise 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 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Global Antibiotics Research and Development Partnership

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jefferson County Department of Health

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

San Francisco Department Of Public Health City Clinic

San Francisco, California, United States

Bell Flower Clinic

Indianapolis, Indiana, United States

Louisiana State University Health Sciences Center

New Orleans, Louisiana, United States

Public Health - Seattle & King County STD Clinic

Seattle, Washington, United States

Institute of Tropical Medicine

Antwerp, , Belgium

Public Health Service (GGD) Amsterdam / STI Outpatient Clinic

Amsterdam, , Netherlands

SAMRC Botha's Hill Clinical Research Site

Bothas Hill, , South Africa

Masiphumelele Research Site

Cape Town, , South Africa

Ndlovu Research Centre

Elandsdoorn, , South Africa

Wits RHI

Johannesburg, , South Africa

Setshaba Research Centre

Soshanguve, , South Africa

SAMRC Tongaat Clinical Research Site

Tongaat, , South Africa

Bangrak STI Center

Bangkok, , Thailand

Institute of HIV Research and Innovation

Bangkok, , Thailand

Silom Community Clinic

Bangkok, , Thailand

Countries

United States; Belgium; Netherlands; South Africa; Thailand

References

Jacobsson S, Golparian D, Oxelbark J, Kong FYS, Da Costa RMA, Franceschi F, Brown D, Louie A, Drusano G, Unemo M. Pharmacodynamics of zoliflodacin plus doxycycline combination therapy against Neisseria gonorrhoeae in a gonococcal hollow-fiber infection model. Front Pharmacol. 2023 Dec 7;14:1291885. doi: 10.3389/fphar.2023.1291885. eCollection 2023.

Reference Type: DERIVED

PMID: 38130409 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2019-000990-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

STI_Zoli001

Identifier Type: -

Identifier Source: org_study_id