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    Summary
    EudraCT Number:2014-003243-34
    Sponsor's Protocol Code Number:D3720C00009
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-22
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-003243-34
    A.3Full title of the trial
    Open-label, Multicentre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and efficacy of Ceftaroline in Neonates and Young Infants with Late-Onset Sepsis
    Studio multicentrico in aperto per valutare la sicurezza, la tollerabilità, la farmacocinetica e l’efficacia di ceftarolina in neonati e nei bambini piccoli con sepsi ad esordio tardivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, Tolerability and Efficacy of Ceftaroline in Babies with Late-Onset Sepsis
    sicurezza, tollerabilità ed efficacia di ceftarolina in bamabini con sepsi ad esordio tardivo
    A.4.1Sponsor's protocol code numberD3720C00009
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/74/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASTRAZENECA AB
    B.1.3.4CountryUnited Kingdom
    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 supportAzienda Farmaceutica: ASTRAZENECA AB - Svezia
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASTRAZENECA AB
    B.5.2Functional name of contact pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressKarlebyhus, Astraallén
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.4Telephone numberNon applicabile
    B.5.5Fax numberNon applicabile
    B.5.6E-mailClinicalTrialTransparency@astrazeneca.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 Zinforo
    D.2.1.1.2Name of the Marketing Authorisation holderASTRA Zeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameZinforo
    D.3.2Product code Non applicabile
    D.3.4Pharmaceutical form Powder for solution for injection/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 INNCEFTAROLINA FOSAMIL STERILE
    D.3.9.1CAS number 229016-73-3
    D.3.9.2Current sponsor codeNon applicabile
    D.3.9.3Other descriptive nameCEFTAROLINE FOSAMIL
    D.3.9.4EV Substance CodeSUB31648
    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
    sepsi ad esordio tardivo
    E.1.1.1Medical condition in easily understood language
    sepsis
    sepsi
    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 18.1
    E.1.2Level HLT
    E.1.2Classification code 10040054
    E.1.2Term Sepsis, bacteraemia, viraemia and fungaemia NEC
    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 evaluate the safety and tolerability of ceftaroline for the treatment of
    Late-onset sepsis in neonates and young infants aged 7 to <60 days
    Valutare sicurezza e tollerabilità di ceftarolina per il trattamento di LOS nei neonati e nei lattanti di età compresa fra 7 e <60 giorni
    E.2.2Secondary objectives of the trial
    To evaluate the PK profile of ceftaroline in neonates and young infants
    aged 7 to <60 days with Late-onset sepsis
    - To evaluate the efficacy of ceftaroline for the treatment of Late-onset
    sepsis in neonates and young infants aged 7 to <60 days
    Valutare il profilo PK di ceftarolina nei neonati e nei lattanti di età compresa fra 7 e <60 giorni con LOS;Valutare l'efficacia di ceftarolina per il trattamento di LOS nei neonati e nei lattanti di età compresa fra 7 e <60 giorni
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent in writing from parent(s) or other legally-acceptable representative(s)
    2. Male or female, gestational age ≥34 weeks, and chronological age 7 to <60 days at the time of screening
    3. Diagnosis of sepsis within 36 hours before enrolment, defined as the presence of at least 2 clinical criteria and at least 2 laboratory criteria in the presence of or as a result of suspected or proven bacterial infection that requires IV antibiotic therapy.
    4. Patients must meet at least two of the following clinical criteria:
    (i) Hypothermia (<36°C) OR fever (>38.5°C)
    (ii) Bradycardia OR tachycardia OR rhythm instability
    (iii) Urine output 0.5 to 1 mL/kg/h OR hypotension OR mottled skin OR impaired peripheral perfusion
    (iv) Petechial rash OR sclerema neonatorum
    (v) New onset or worsening of apnoea episodes OR tachypnoea episodes OR increased oxygen requirements OR requirement for ventilation support
    (vi) Feeding intolerance OR poor sucking OR abdominal distension
    (vii) Irritability
    (viii) Lethargy
    (ix) Hypotonia.
    5. Patients must meet at least two of the following laboratory criteria:
    (i) White blood cell count ≤4,000 × 109/L OR ≥20,000 × 109/L
    (ii) Immature to total neutrophil ratio >0.2
    (iii) Platelet count ≤100,000 × 109/L
    (iv) C-reactive protein (CRP) >15 mg/L OR procalcitonin ≥2 ng/mL
    (v) Hyperglycaemia OR Hypoglycaemia
    (vi) Metabolic acidosis
    1. Consenso informato scritto da parte dei genitori o altri legali rappresentanti
    2. Maschio o femmina, età gestazionale ≥34 settimane ed età anagrafica compresa fra 7 e <60 giorni al momento dello screening
    3. Diagnosi di sepsi nei 36 giorni precedenti l'arruolamento, definita come l'esistenza di almeno 2 criteri clinici e almeno 2 criteri di laboratorio in presenza o come conseguenza di un'infezione batterica sospetta o dimostrata che richiede una terapia antibiotica EV.
    4. I pazienti devono soddisfare almeno due dei seguenti criteri clinici:
    (i) Ipotermia (<36 °C) O febbre (>38,5 °C)
    (ii) Bradicardia O tachicardia O instabilità del ritmo
    (iii) Produzione di urina compresa fra 0,5 e 1 ml/kg/h O ipotensione O chiazze cutanee O perfusione periferica compromessa
    (iv) Eruzione petecchiale O sclerema neonatorum
    (v) Nuova insorgenza o peggioramento di episodi di apnea O episodi di tachipnea O maggiore richiesta di ossigeno O necessità di supporto ventilatorio
    (vi) Intolleranza alimentare O scarse poppate O distensione addominale
    (vii) Irritabilità
    (viii) Letargia
    (ix) Ipotonia.
    5. I pazienti devono soddisfare almeno due dei seguenti criteri di laboratorio:
    (i) Conta leucocitaria ≤4000 × 109/l O ≥20000 × 109/l
    (ii) Rapporto neutrofili immaturi/totali >0,2
    (iii) Conta piastrinica ≤100000 × 109/l
    (iv) Proteina C reattiva (CRP) >15 mg/l O procalcitonina ≥2 ng/ml
    (v) Iperglicemia O ipoglicemia
    (vi) Acidosi metabolica
    E.4Principal exclusion criteria

    1. Documented history of any hypersensitivity or allergic reaction to any β-lactam antibiotic or aminoglycoside
    2. At study entry, has confirmed infection with a pathogen known to be resistant to the combination of ceftaroline fosamil, ampicillin, and the optional aminoglycoside of choice OR confirmed viral, fungal, or parasitic pathogen as the sole cause of infection
    3. Refractory septic shock within 24 hours before enrolment that does not resolve after 60 minutes of vasopressor therapy
    4. Moderate or severe renal impairment defined as serum creatinine ≥2 times the upper limit of normal (× ULN) for age OR urine output <0.5 mL/kg/h (measured over at least 8 hours) OR requirement for dialysis
    5. Evidence of progressively fatal underlying disease, or life expectancy of ≤60 days
    6. Documented history of seizure
    7. Requiring or currently taking antiretroviral therapy for human immunodeficiency virus (HIV) or a child from an HIV positive mother
    8. Proven or suspected central nervous system (CNS) infection (eg, meningitis, brain abscess, subdural abscess), osteomyelitis, endocarditis, or necrotizing enterocolitis (NEC)
    9. Any condition (eg, cystic fibrosis, urea cycle disorders), antepartum/peripartum factors, or procedures that would, in the opinion of the investigator, make the patient unsuitable for the study, place a patient at risk, or compromise the quality of data
    10. Patient's parent(s) or legally-acceptable representative(s) involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Concurrent participation in another clinical study with an investigational product (IP), previous enrolment/participation in this study, or participation in another study of ceftaroline fosamil within 14 days before the intended start of the first dose of study therapy
    1. Anamnesi documentata di ipersensibilità o reazione allergica a qualsiasi antibiotico
    β-lattamico o amminoglicosidico
    2. Presenza, all'ingresso nello studio, di un'infezione confermata causata da un patogeno noto per essere resistente all'associazione ceftarolina fosamil, ampicillina e amminoglicoside opzionale di elezione O conferma di infezione causata unicamente da un agente virale, fungino o parassitario
    3. Shock settico refrattario nelle 24 ore precedenti l'arruolamento, che non si risolve dopo 60 minuti di terapia con un vasopressore
    4. Insufficienza renale moderata o grave definita come livello di creatinina nel siero ≥2 volte il limite superiore della norma (× ULN) specifico per l'età O produzione di urina <0,5 ml/kg/h (misurata su almeno 8 ore) O requisiti per la dialisi
    5. Evidenza di patologia letale progressiva sottostante o aspettativa di vita ≤60 giorni
    6. Anamnesi documentata di crisi convulsive
    7. Necessità o assunzione di terapia antiretrovirale per il virus dell'immunodeficienza umano (HIV) o bambino nato da una madre HIV positiva
    8. Infezione, sospetta o comprovata, del sistema nervoso centrale (CNS) (ad es., meningite, ascesso cerebrale, ascesso subdurale), osteomielite, endocardite o enterocolite necrotizzante (NEC)
    9. Qualsiasi condizione (ad es. fibrosi cistica, disturbi del ciclo dell'urea), fattori anteparto o periparto o procedure che potrebbero, in base alla valutazione dello sperimentatore, rendere il paziente non idoneo allo studio, esporre il paziente a rischi o compromettere la qualità dei dati
    10. Coinvolgimento dei genitori o dei legali rappresentanti nella pianificazione e/o conduzione dello studio (valido anche per il personale Astra Zeneca e quello del centro dello studio). Partecipazione contemporanea a un altro studio clinico con un prodotto sperimentale (IP, Investigational Product), precedente arruolamento/partecipazione a questo studio o partecipazione a un altro studio su ceftarolina fosamil nei 14 giorni precedenti la somministrazione prevista della prima dose della terapia dello studio
    E.5 End points
    E.5.1Primary end point(s)
    The safety analysis will be performed on the Safety Analysis Set (all subjects who received drug) and will include AEs, SAEs, deaths, clinical laboratory parameters and vital signs.
    Il set di analisi della sicurezza includerà tutti i pazienti che hanno ricevuto una qualsiasi quantità di farmaco. I parametri di sicurezza comprendono AE, SAE, decessi, parametri clinici di laboratorio e segni vitali.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Duration of study including safety follow up visit
    Durata dello studio inclusa la visita di Follow up sulla sicurezza
    E.5.2Secondary end point(s)
    1. Concentrations of ceftaroline fosamil, ceftaroline, and ceftaroline M-1 in plasma (and if available, concentrations of ceftaroline and ceftaroline M-1 in cerebrospinal fluid [CSF]) 2. Efficacy outcome measures will include clinical outcome at EOT and TOC in the Modified Intent-to- Treat (MITT) Analysis Set.
    1.Concentrazioni di ceftarolina fosamil, ceftarolina e ceftarolina M-1 nel plasma (e se disponibili, concentrazioni di ceftarolina e ceftarolina M-1 nel liquido cerebrospinale [CSF]) 2.Gli esiti di efficacia che includeranno esito clinico a EOT e TOC nel set di analisi "Modified Intent-to-Treat" MITT
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Treatment period at time of sampling 2. End of Therapy vist and Test of Cure visit
    1. Periodo di trattamento al tempo del campionamento 2. alla Visita di fine terapia e alla visita del Test di guarigione
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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
    Hungary
    Italy
    Spain
    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
    LVLS
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    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: 24
    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: 8
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 8
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 8
    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
    paediatrics
    pazienti pediatrici
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 13
    F.4.2.2In the whole clinical trial 24
    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)
    After participation in the trial, if applicable, patients will be treated with the current standard therapy.
    Dopo la partecipazione allo studio , se applicabile, i pazienti saranno trattati con lo standard di cura
    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 Decision2015-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-30
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