Zoliflodacin in Uncomplicated Gonorrhoea
Purpose
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
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥ 12 years old (if enrolment of minors is in agreement with local regulations and thics 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
- 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Single dose of Zoliflodacin or comparators combination in single dose: ceftriaxone and azithromycin
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental zoliflodacin |
Participant in this arm will receive a single dose of zoliflodacin. |
|
|
Active Comparator ceftriaxone and azithromycin combination |
Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Global Antibiotics Research and Development Partnership