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Zoliflodacin in Uncomplicated Gonorrhoea

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ClinicalTrials.gov Identifier: NCT03959527
Recruitment Status : Active, not recruiting
First Posted : May 22, 2019
Last Update Posted : May 12, 2023
Sponsor:
Information provided by (Responsible Party):
Global Antibiotics Research and Development Partnership

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gonorrhea Drug: zoliflodacin Drug: ceftriaxone Drug: azithromycin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1092 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single dose of Zoliflodacin or comparators combination in single dose: ceftriaxone and azithromycin
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Open-label, Non Inferiority Trial to Evaluate the Efficacy and Safety of a Single, Oral Dose of Zoliflodacin Compared to a Combination of a Single Intramuscular Dose of Ceftriaxone and a Single Oral Dose of Azithromycin in the Treatment of Patients With Uncomplicated Gonorrhoea
Actual Study Start Date : November 6, 2019
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : December 10, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gonorrhea

Arms and Interventions
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Arm Intervention/treatment
Experimental: zoliflodacin
Participant in this arm will receive a single dose of zoliflodacin.
 Drug: zoliflodacin
Dose: 3g, oral administration
Active Comparator: ceftriaxone and azithromycin combination
Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).
 Drug: ceftriaxone
Dose: 500mg, Intra-Muscular (IM) administration

Drug: azithromycin
Dose: 1g, oral administration


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of a single dose of zoliflodacin will be assessed compared to a combination of a single dose of ceftriaxone and azithromycin. [ Time Frame: Day 6 ]
    Microbiological cure as determined by culture at urethral or cervical sites at test of cure visit.


Secondary Outcome Measures :
  1. Safety of a single dose of zoliflodacin will be assessed compared to a combination a single dose of ceftriaxone and azithromycin. [ Time Frame: Day 6 and Day 30 ]
    Adverse events will be assessed.

  2. Microbiological cure rate of pharyngeal gonorrhoea will be determined after administration of a single dose of zoliflodacin compared to a combination of a single dose of ceftriaxone and azithromycin. [ Time Frame: Day 6 ]
    Proportion of participants with microbiological cure as determined by culture at pharyngeal sites at test of cure visit.

  3. Microbiological cure rate of rectal gonorrhoea will be determined after administration of a single dose of zoliflodacin compared to a combination of a single dose of ceftriaxone and azithromycin. [ Time Frame: Day 6 ]
    Proportion of participants with microbiological cure as determined by culture at rectal sites at test of cure visit.

  4. The clinical cure rate of symptomatic gonorrhoea in male participants will be determined after administration of a single dose of zoliflodacin compared to a combination of single dose of ceftriaxone and azithromycin. [ Time Frame: Day 6 ]
    Proportion of male participants with clinical cure at test of cure visit.

  5. Microbiological cure rate of urogenital gonorrhoea will be determined among women and men respectively, after administration of a single dose of zoliflodacin compared to a combination of a single dose of ceftriaxone and azithromycin. [ Time Frame: Day 6 ]
    Proportion of female and male participants respectively with microbiological cure as determined by culture at cervical or urethral site at test of cure visit.

  6. Microbiological cure rate of Neisseria gonorrhoeae (NG) at urogenital sites will be determined. [ Time Frame: Day 6 ]
    Proportion of participants with microbiological cure as determined by culture at urethral or cervical sites at the test of cure visit and for whom the baseline antimicrobial susceptibility profile indicated pre-existing resistance to antibiotics commonly used for Neisseria gonorrhoeae (NG) treatment.

  7. Antimicrobial susceptibility profile will be determined of gonococcal strains isolated from participants with uncomplicated gonorrhoea at baseline and the test of cure visit. [ Time Frame: Day 6 ]
    Antimicrobial susceptibility profile of gonococcal strains isolated at baseline and at test of cure visit.

  8. The eradication rate of NG nucleic acid will be determined from urogenital rectal, pharyngeal specimens after administration of a single dose of zoliflodacin compared to a combination of a single dose of ceftriaxone and azithromycin. [ Time Frame: Day 6 ]
    Proportion of participants with a negative NG NAAT from urethral or cervical, oropharyngeal and rectal sites at test of cure visit.

  9. The plasma concentration will be evaluated (included Area Under the Curve (AUC) over 36 hours) after a single dose of zoliflodacin. [ Time Frame: Day 2 ]
    Five PK timepoints post-treatment will be assessed.


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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:

  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959527


Locations
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Sponsors and Collaborators
Global Antibiotics Research and Development Partnership
More Information
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Responsible Party: Global Antibiotics Research and Development Partnership
ClinicalTrials.gov Identifier: NCT03959527    
Other Study ID Numbers: STI_Zoli001
2019-000990-22 ( EudraCT Number )
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 12, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gonorrhea
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Communicable Diseases
Genital Diseases
Urogenital Diseases
Azithromycin
 Ceftriaxone
Zoliflodacin
Anti-Bacterial Agents
Anti-Infective Agents
Third Generation Cephalosporins
Beta Lactam Antibiotics
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents