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    Summary
    EudraCT Number:2019-002768-28
    Sponsor's Protocol Code Number:W-5222-301
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-05-16
    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 ConcernedEstonia - SAM
    A.2EudraCT number2019-002768-28
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Efficacy and Safety of Cefepime-zidebactam vs. Meropenem in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 study of an Investigational Drug, Cefepime-zidebactam versus Meropenem in patients with Complicated Urinary Tract Infection or Acute Pyelonephritis
    A.4.1Sponsor's protocol code numberW-5222-301
    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 SponsorWockhardt Bio AG
    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 supportWockhardt Bio AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace Inc
    B.5.2Functional name of contact pointWojciech Gutman
    B.5.3 Address:
    B.5.3.1Street Addressul. Zwirki i Wigury 16C
    B.5.3.2Town/ cityWarsaw
    B.5.3.3Post code02-092
    B.5.3.4CountryPoland
    B.5.4Telephone number+482237012702481
    B.5.6E-mailw.gutman@medpace.com
    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 nameCefepime-zidebactam
    D.3.2Product code WCK 5222 (FEP-ZID)
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCEFEPIME HYDROCHLORIDE
    D.3.9.1CAS number 123171-59-5
    D.3.9.4EV Substance CodeSUB01113MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZidebactam
    D.3.9.1CAS number 1436861-97-0
    D.3.9.3Other descriptive nameWCK 5107
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Meronem (meropenem powder for solution for infusion )
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Italia S.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMEROPENEM
    D.3.9.3Other descriptive nameMEROPENEM TRIHYDRATE
    D.3.9.4EV Substance CodeSUB21617
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Complicated urinary tract infection or acute pyelonephritis
    E.1.1.1Medical condition in easily understood language
    Complicated urinary tract infection or acute pyelonephritis
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10080628
    E.1.2Term Complicated urinary tract infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10001032
    E.1.2Term Acute pyelonephritis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To demonstrate that cefepime-zidebactam (FEP-ZID) is non-inferior to meropenem in overall success (clinical cure and microbiological eradication) in the microbiological Modified Intent-to-treat (mMITT) population at the Test-of-Cure (TOC) visit
    • To assess the overall safety and tolerability of FEP-ZID in the Safety population
    E.2.2Secondary objectives of the trial
    • To evaluate the overall outcome at TOC in the Clinically Evaluable (CE) and Microbiological Evaluable (ME) populations
    • To evaluate the overall outcome at End-of-Treatment (EOT) in the mMITT population
    • To evaluate the clinical outcomes at EOT (mMITT population) and at TOC (mMITT, CE and ME populations)
    • To evaluate the microbiological outcome at EOT (mMITT population) and TOC (mMITT, CE and ME populations)
    • To evaluate the by-pathogen overall outcome (mMITT, CE and ME populations) as well as by-pathogen clinical (mMITT and CE populations) and microbiological outcomes (mMITT and ME populations) at TOC
    • To evaluate the clinical outcome at Late Follow-Up (LFU) in the mMITT population
    • To evaluate the pharmacokinetics (PK) of FEP-ZID in adult subjects with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female 18 years or older
    2. Able to provide signed informed consent
    3. Have a diagnosis of complicated urinary tract infection (cUTI) or acute pyelonephritis (AP)
    4. Have evidence of pyuria
    5. If available, have a Gram-negative pathogen susceptible to meropenem cultured from the urine
    5. Requires hospitalization to manage the cUTI or AP
    6. Agree to use effective methods of contraception
    E.4Principal exclusion criteria
    1. Know or suspected disease that may confound the assessment of efficacy.
    2. Receipt of more than 72 hours of prior antibiotic therapy except for those failing prior antibiotic therapy
    3. Rapidly progressive illness such that the subject is unlikely to survive the study period.
    4. Pregnant or breastfeeding females
    5. History of a seizure disorder requiring current treatment
    6. Creatinine clearance < 15 mL/min or on renal dialysis
    7. Neutropenia or elevated liver enzymes
    8. Hypersensitivity to beta-lactam antibiotics
    9. Unlikely to comply with the protocol or the Investigator considers that study participation may not be optimal for the subject.
    E.5 End points
    E.5.1Primary end point(s)
    1. Overall Outcome at TOC
    - Overall Success: clinical cure and microbiological eradication
    - Overall Failure: clinical failure or microbiological persistence
    - Overall Indeterminate: Study data are missing for evaluation of efficacy or microbiological outcome for any reason, and the subject cannot otherwise be declared an overall failure at TOC

    2. Evaluation of safety based on adverse events, clinical laboratory evaluations, vital signs, electrocardiograms collected during the study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome at TOC is determined at Study Day 17
    E.5.2Secondary end point(s)
    1. Overall outcome at End-of-Treatment (EOT)
    2. Clinical outcomes at EOT
    3. Microbiological outcome at EOT
    4. By-pathogen overall outcome as well as by-pathogen clinical and microbiological outcomes at TOC
    5. Clinical outcome at Late Follow-Up
    6. To evaluate the pharmacokinetics (PK) of FEP-ZID in the study population
    E.5.2.1Timepoint(s) of evaluation of this end point
    Outcome timepoint is determined by study treatment days, ToC visit (Day 17) and clinical outcome at LFU (day 26)
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Peru
    Belarus
    China
    India
    Mexico
    United States
    Bulgaria
    Estonia
    Lithuania
    Poland
    Slovakia
    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
    Last Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months19
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months31
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 128
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 528
    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)
    Standard of Care
    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 Decision2022-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-11-25
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