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    Summary
    EudraCT Number:2016-004800-71
    Sponsor's Protocol Code Number:1230_OPBG_2016
    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:2016-12-19
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-004800-71
    A.3Full title of the trial
    Determination of intraoperative levels of Cefoxitin during cardiac surgery requiring cardiopulmonary bypass in neonates, infants, children below, and above 40 kg.
    Determinazione dei livelli plasmatici intraoperatori di Cefoxitina durante cardiochirurgia in circolazione extracorporea su neonati, lattanti, e bambini al di sotto e al di sopra dei 40 kg di peso
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Determination of plasma levels of Cefoxitin during cardiac surgery on newborns, infants, and children under and over 40 kg weight
    Determinazione dei livelli plasmatici di Cefoxitina durante cardiochirurgia su neonati, lattanti, e bambini al di sotto e al di sopra dei 40 kg di peso
    A.4.1Sponsor's protocol code number1230_OPBG_2016
    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 SponsorBambino Gesù Children's Hospital
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBambino Gesù Children's Hospital
    B.5.2Functional name of contact pointChiara Mennini
    B.5.3 Address:
    B.5.3.1Street AddressPiazza Sant’Onofrio 4
    B.5.3.2Town/ cityRome
    B.5.3.3Post code00165
    B.5.3.4CountryItaly
    B.5.4Telephone number00390668592572
    B.5.5Fax number00390668594547
    B.5.6E-mailchiara.mennini@opbg.net
    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 Mefoxin
    D.2.1.1.2Name of the Marketing Authorisation holderIstituto Biochimico Nazionale Savio S.r.l. Sede Legale
    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.3.1Product nameCefoxitina
    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.3.11 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
    Antibiotic prophylaxis for surgical procedure using cardiopulmonary bypass in children with congenital heart disease.
    Profilassi antibiotica per procedura chirurgica mediante Bypass Cardiopolmonare in bambini con cardiopatia congenita.
    E.1.1.1Medical condition in easily understood language
    Antibiotic prophylaxis for surgical procedure using cardiopulmonary bypass in children with congenital heart disease.
    Profilassi antibiotica per procedura chirurgica mediante Bypass Cardiopolmonare in bambini con cardiopatia congenita.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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 study the pharmacokinetic profile of cefoxitin administered, as antibiotic prophylaxis to children undergoing elective CPB.
    Studiare il profilo intraoperatorio di farmacocinetica della cefoxitina, somministrata profilatticamente a pazienti pediatrici affetti da cardiopatia congenita che necessitano di una procedura chirurgica mediante Bypass Cardiopolmonare
    E.2.2Secondary objectives of the trial
    • To evaluate if a significant difference in blood levels will occur in the four predetermined patients’ categories.
    • To evaluate the role of hemodilution during CPB on studied antibiotic’s serum concentration
    • To verify the incidence of post-operative infections in the studied population with particular attention to sensitive bacteria
    • To evaluate the impact of ultrafiltration in studied antibiotic’s clearance
    • To evaluate safety of the administered antibiotic
    valutare una differenza significativa dei livelli ematici della cefoxitina tra le quattro categorie di pazienti pediatrici.
    • valutare il ruolo della emodiluizione durante la CPB sulla concentrazione sierica dell’antibiotico studiato
    • verificare l'incidenza di infezioni post-operatorie nella popolazione studiata con particolare attenzione ai batteri sensibili
    • valutare l'impatto dell’ ultrafiltrazione nella clearance dell’antibiotico studiato
    • valutare la sicurezza dell'antibiotico somministrato
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Elective cardiac surgery schedule with the planned application of CPB.
    -Parents of elegible children, or their legal representative, able to consent and comply with protocol requirements.
    -Intervento cardiochirurgico mediante CPB che necessiti di profilassi con cefoxitina in pazienti pediatrici
    -Ottenimento del consenso informato
    E.4Principal exclusion criteria
    -Urgent or emergent surgery
    -Antibiotic therapy (any) administered before surgery
    -Patients receiving, before surgery, any other form of extracorporeal treatment (i.e ECMO, CRRT)
    -Previous renal or hepatic dysfunction requiring need for antibiotic posology modification.
    -Surgery requiring antibiotic prophylaxis with different drug combinations (i.e vancomycin and gentamycin)
    -ELBW neonates.
    -Procedure di urgenza
    -Pazienti sottoposti a terapia antibiotica prima della chirurgia
    -Pazienti sottoposti, prima della chirurgia, a Extracorporeal Membrane Oxygenation
    -Presenza di disfunzione renale o epatica preoperatoria (che richiedano o meno aggiustamento del dosaggio degli antibiotici in profilassi)
    --Procedure con profilassi antibiotica differente (i.e. vancomicina e gentamicina).
    E.5 End points
    E.5.1Primary end point(s)
    Quantification of cefoxitin blood levels, through samples collected after anesthesia induction. Blood draws are to be taken at skin incision (approximately one hour after cefoxitin bolus), 15 minutes after CPB start (CPB1), at the end of CPB (CPB2) and at the end of surgery.
    Quantificazione dei livelli ematici cefoxitina, attraverso campioni raccolti dopo l'induzione dell'anestesia. I campioni di sangue seriati verranno prelevati in concomitanza dell’incisione cutanea (circa un'ora dopo il bolo di cefoxitina), 15 minuti dopo la procedura chirurgica mediante CPB (CPB1), alla fine della procedura chirurgica mediante CPB (CPb2) e alla fine dell'intervento. Al termine della CPB verrà effettuato un prelievo di ultrafiltrato dalla sacca di raccolta
    E.5.1.1Timepoint(s) of evaluation of this end point
    The day of prophylactic therapy coincides with the day of the surgical procedure
    Il giorno della terapia profilattica coincidente con il giorno della procedura chirurgica
    E.5.2Secondary end point(s)
    To compare peak and through values in neonates, infants, children weighting less than 40 kg and children weighting more than 40 kg
    To evaluate the impact of CPB volume with respect of patients’ body weight, including the amount of fluids (crystalloids, colloids and hemoderivatives) administered intraoperatively to studied patients, on the enrolled patients
    The incidence of post-operative infections in the studied population with particular attention to sensitive bacteria (including methicillin resistant staphylococcus aureus) will be recorded throughout patients’ PCICU admission.
    The concentration of cefoxitin in the ultrafiltrate (UF) and their total removal will be evaluated at the end of CPB (UF1) from the total UF volume. The UF volume will be specifically recorded. Antibiotic’s sieving coefficient (SC) will be calculated as UF1/[(CPB1+CPB2)/2]. Antibiotic clearance will be calculated as SC*UF rate (ml/min).Evaluation of adverse events (serious and non-serious) and adverse drug reactions throughout the duration of trial by assessment of physical examination, vital signs, 12-lead electrocardiogram. Serious and non-serious adverse events will be collected intra-operatively.
    Confrontare i livelli plasmatici di cefoxitina nei neonati, bambini di peso inferiore a 40 kg e bambini di peso superiore a 40 kg.
    Valutare l'impatto del volume del CPB rispetto al peso corporeo del paziente, compresa la quantità di liquidi (cristalloidi, colloidi e emoderivati), somministrato durante l'intervento per i arruolati
    Valutare l'incidenza di infezioni post-operatorie nella popolazione studiata con particolare attenzione ai batteri sensibili (compresi resistente alla meticillina Staphylococcus aureus)
    Determinare la concentrazione di cefoxitin nell'ultrafiltrato (UF) e la sua eliminazione totale, alla fine del CPB (UF1), dal volume totale UF. Il volume UF sarà specificamente registrato. Il Coefficiente di sieving dell’antibiotico (SC) sarà calcolato come UF1 / [(+ CPB1 CPb2) / 2]. La clearance dell’antibiotico sarà calcolata come SC * tasso di UF (ml / min) .
    Valutare gli eventi avversi (gravi e non gravi) e le reazioni avverse per tutta la durata dello studio attraverso la valutazione dei parametri fisici, dei segni vitali, dell'elettrocardiogramma.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.The day of the prophylactic treatment coincident with the surgical procedure (from 1 hour before surgical incision);
    2. Each visit postoperatively;
    3. Last day coinciding with the discharge from the cardio surgical intensive care
    1. Il giorno del trattamento profilattico coincidente con la procedura chirurgica (da 1 ora prima dell’incisione chirurgica);
    2. Ogni visita nel post operatorio;
    3. Ultimo giorno coincidente con la dimissione dalla terapia intensiva cardio chirurgica
    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 No
    E.6.5Efficacy No
    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 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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    Ultima visita dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 10
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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 Decision2017-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
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