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    Summary
    EudraCT Number:2019-000990-22
    Sponsor's Protocol Code Number:STI_Zoli001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2021-12-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-000990-22
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    No
    A.4.1Sponsor's protocol code numberSTI_Zoli001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03959527
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGARDP FOUNDATION
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGARDP FOUNDATION
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGARDP FOUNDATION
    B.5.2Functional name of contact pointAmalia Droal
    B.5.3 Address:
    B.5.3.1Street Address15 Chemin Camille-Vidart
    B.5.3.2Town/ cityGeneva
    B.5.3.3Post code1202
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4122 555 19 77
    B.5.6E-mailadroal@gardp.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameZoliflodacin
    D.3.2Product code ETX0914
    D.3.4Pharmaceutical form Granules for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZoliflodacin
    D.3.9.1CAS number 1620458-09-4
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ceftriaxon Hexal 0.5 g Powder for solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderHexal
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCEFTRIAXONE
    D.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCEFTRIAXONE SODIUM
    D.3.9.1CAS number 74578-69-1
    D.3.9.4EV Substance CodeSUB01138MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Azithromycin 250 mg film-coated tablet
    D.2.1.1.2Name of the Marketing Authorisation holderRatiopharm
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAzithromycin
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZITHROMYCIN MONOHYDRATE
    D.3.9.1CAS number 121470-24-4
    D.3.9.4EV Substance CodeSUB87696
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Uncomplicated gonorrhoea
    E.1.1.1Medical condition in easily understood language
    Gonorrhoea is a sexually transmitted disease from bacterial origin that is transmitted through unprotected oral, anal, or vaginal sex.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of a single, oral, 3 grams (g) dose of zoliflodacin compared to a combination of a single intramuscular (IM) 500 milligram (mg) dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment of uncomplicated urogenital gonorrhoea.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of a single, oral, 3 g dose of zoliflodacin compared to a combination of a single IM 500 mg dose of ceftriaxone and a single 1 g oral
    dose of azithromycin in participants with uncomplicated gonorrhoea
    To determine microbiological cure rate of pharyngeal gonorrhoea after administration of a single, oral, 3 g dose of zoliflodacin compared to a combination of a single IM 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin
    To determine microbiological cure rate of rectal gonorrhoea after administration of a single, oral, 3 g dose of zoliflodacin compared to a combination of a single IM 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin
    To determine the clinical cure rate of symptomatic gonorrhoea in male participants after administration of a single, oral, 3 g dose of zoliflodacin compared to a combination of a single IM 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Pharmacokinetics of zoliflodacin in participants with uncomplicated gonorrhoea following a single 3 g oral dose administration.
    The plasma concentration of zoliflodacin will be determined in the following subsets of participants:
    - in human immunodeficiency virus (HIV) negative adult participants and HIV positive participants (≥ 18 years old)
    - in HIV negative adolescent participants (≥ 12 and < 18 years old)
    E.3Principal 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)
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    Microbiological cure as determined by culture at urethral or cervical sites
    E.5.1.1Timepoint(s) of evaluation of this end point
    At test of cure (TOC) visit ( day 6+/- 2days).
    E.5.2Secondary end point(s)
    Incidence, severity, causality, and seriousness of treatment-emergent adverse events and the evaluation of changes from baseline in safety laboratory test results and physical examinations
    Proportion of participants with microbiological cure as determined by culture at pharyngeal sites at TOC (day 6 ±2)
    Proportion of participants with microbiological cure as determined by culture at rectal sites at TOC (day 6 ±2)
    Proportion of male participants with clinical cure at TOC (day 6 ±2)
    Proportion of female and male participants respectively with microbiological cure as determined by culture at cervical or urethral site at TOC (day 6 ±2)
    Proportion of participants with microbiological cure as determined by culture at urethral or cervical sites at TOC and for whom the baseline antimicrobial susceptibility profile indicated pre-existing resistance to antibiotics commonly used for NG treatment (including to ceftriaxone alone, to azithromycin alone, and to both)
    Antimicrobial susceptibility profile of gonococcal strains isolated at baseline and at TOC (day 6 ±2)
    Proportion of participants with a negative NG nucleic acid amplification test (NAAT) from urethral or cervical sites at TOC (day 6 ±2)
    Proportion of participants with a negative NG NAAT from oropharyngeal sites at TOC (day 6 ±2)
    Proportion of participants with a negative NG NAAT from rectal sites at TOC (day 6 ±2)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At test of cure (TOC) visit ( day 6+/- 2days).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    South Africa
    Thailand
    Belgium
    Netherlands
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 100
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 992
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 1092
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-02-23
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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