Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Zoliflodacin in Uncomplicated Gonorrhoea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03959527
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Global Antibiotics Research and Development Partnership

Tracking Information
First Submitted Date  ICMJE May 2, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE September 27, 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03959527 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zoliflodacin in Uncomplicated Gonorrhoea
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Gonorrhea
Intervention  ICMJE
  • Drug: zoliflodacin
    Dose: 3g, oral administration
  • Drug: ceftriaxone
    Dose: 500mg, Intra-Muscular (IM) administration
  • Drug: azithromycin
    Dose: 1g, oral administration
Study Arms  ICMJE
  • Experimental: zoliflodacin
    Participant in this arm will receive a single dose of zoliflodacin.
    Intervention: Drug: zoliflodacin
  • Active Comparator: ceftriaxone and azithromycin combination
    Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).
    Interventions:
    • Drug: ceftriaxone
    • Drug: azithromycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
1092
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 15 years old
  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 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jessica Renaux +41 22 555 19 06 jrenaux@gardp.org
Listed Location Countries  ICMJE Netherlands,   South Africa,   Thailand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959527
Other Study ID Numbers  ICMJE STI_Zoli001
2019-000990-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Global Antibiotics Research and Development Partnership
Study Sponsor  ICMJE Global Antibiotics Research and Development Partnership
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Global Antibiotics Research and Development Partnership
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP