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    Summary
    EudraCT Number:2022-001837-35
    Sponsor's Protocol Code Number:BPR-PIP-003
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-08-17
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2022-001837-35
    A.3Full title of the trial
    A multicenter, open-label, single-arm, multiple-dose study to evaluate the safety,
    pharmacokinetics, and efficacy of ceftobiprole medocaril in term and pre-term
    neonates and infants up to 3 months of age with late-onset sepsis
    Daugiacentris, atviras, vienos grupės, kelių dozių tyrimas, skirtas įvertinti Ceftobiprolio medokarilio saugumą, farmakokinetiką ir veiksmingumą išnešiotiems ir neišnešiotiems naujagimiams bei kūdikiams iki 3 mėnesių, kuriems pasireiškė vėlyvas sepsis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Late-onset sepsis in term and pre-term neonates and infants up to 3 months of age
    A.4.1Sponsor's protocol code numberBPR-PIP-003
    A.5.4Other Identifiers
    Name:IND NumberNumber:64.407
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/529/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBasilea Pharmaceutica International Ltd, Allschwil
    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 supportBasilea Pharmaceutica International Ltd, Allschwil
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBasilea Pharmaceutica International Ltd, Allschwil
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressHegenheimermattweg 167b
    B.5.3.2Town/ cityAllschwil
    B.5.3.3Post code4123
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41616061111
    B.5.6E-mailmedical.information@basilea.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 Yes
    D.2.1.1.1Trade name Zevtera®
    D.2.1.1.2Name of the Marketing Authorisation holderCorrevio
    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 nameCeftobiprole medocaril
    D.3.4Pharmaceutical form Powder for concentrate 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 INNCeftobiprole medocaril
    D.3.9.1CAS number 252188-71-9
    D.3.9.4EV Substance CodeSUB25721
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number666.6
    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
    Late-onset sepsis (LOS) in term and pre-term neonates and
    infants up to 3 months of age.
    E.1.1.1Medical condition in easily understood language
    Body's extreme reaction to bacterial infection in newborns.
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10053598
    E.1.2Term Late onset neonatal sepsis
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterise the safety profile of ceftobiprole in term and pre-term neonates and infants
    up to 3 months of age with LOS.
    E.2.2Secondary objectives of the trial
    To assess in term and pre-term neonates and infants up to 3 months of age with LOS treated
    with ceftobiprole:
    - PK of ceftobiprole
    - Clinical response
    - All-cause mortality
    - Microbiological response
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent from parent(s) or other legally-acceptable representative (LAR) to participate in the study
    2. Male or female, with a gestational age of ≥ 24 weeks and a post-natal age ranging from ≥ 3 days to ≤ 3 months
    3. Diagnosis of documented or presumed bacterial LOS requiring administration of systemic antibiotic treatment.
    4. Sufficient vascular access to receive study drug and to allow blood sampling at a site separate from the study drug infusion line
    E.4Principal exclusion criteria
    1. Refractory septic shock not responding to 60 minutes of vasopressor treatment within 48 hours before enrollment
    2. Proven ventilator-associated pneumonia
    3. Proven central nervous system infection (e.g., meningitis, brain abscess)
    4. Proven osteomyelitis, infective endocarditis, or necrotising enterocolitis
    5. Impaired renal function or known significant renal disease, as evidenced by an estimated glomerular filtration rate (using the Schwartz formula or other applicable formula) calculated to be less than 2/3 of normal for the applicable age group, OR urinary output < 0.5 mL/kg/h (measured over at least 8 hours), OR requirement for dialysis
    6. Progressively fatal underlying disease, or life expectancy < 30 days
    7. Use of systemic antibacterial therapy for longer than 72 hours within 7 days before start of study medication
    8. Participation in another clinical study with an investigational product within 30 days of enrollment in the current study
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is safety and tolerability in the Safety population, as assessed by adverse events (AEs), serious adverse events (SAEs), deaths, and discontinuations due to AEs during treatment with ceftobiprole and at the end of treatment (EOT), test of cure (TOC), and
    last follow-up (LFU) visits, as well as clinical laboratory tests, vital signs, and physical examination findings.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the EOT, TOC, and LFU visits, as well as clinical laboratory tests, vital signs, and physical examination findings.
    E.5.2Secondary end point(s)
    Pharmacokinetics
    - Plasma levels of ceftobiprole, ceftobiprole medocaril, and the open-ring metabolite in the PK population
    Efficacy
    - Clinical cure rate at the EOT and TOC visits (ITT and CE populations)
    - All-cause mortality through Day 28 (ITT population)
    - Microbiological eradication or presumed eradication rate at the EOT and TOC visits (mITT and ME populations)
    - Improved signs and symptoms of LOS at the Day 3, EOT, and TOC visits (ITT and CE populations)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Day 3, Day 28, EOT and TOC visit.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA15
    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
    United States
    Bulgaria
    Estonia
    Germany
    Hungary
    Latvia
    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
    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 months4
    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 months4
    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: 15
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 10
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 3
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 No
    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
    Pre-term and term neonates, age up to 3 months.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 15
    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 Decision2023-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-08
    P. End of Trial
    P.End of Trial StatusOngoing
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