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    Summary
    EudraCT Number:2013-000309-21
    Sponsor's Protocol Code Number:PREDICT_Trial
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-06-07
    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 number2013-000309-21
    A.3Full title of the trial
    Antibiotic Prophylaxis and Renal Damage In Congenital abnormalities of the kidney and urinary Tract
    Profilassi antibiotica e danno renale nelle anomalie congenite del rene e delle vie urinarie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antibiotic Prophylaxis and Renal Damage In Congenital abnormalities of the kidney and urinary Tract
    Profilassi antibiotica e danno renale nelle anomalie congenite del rene e delle vie urinarie
    A.3.2Name or abbreviated title of the trial where available
    PREDICT_Trial
    PREDICT_Trial
    A.4.1Sponsor's protocol code numberPREDICT_Trial
    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 SponsorAOU di Bologna, Policlinico S.Orsola-Malpighi
    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 supportMinistero della Salute, Project Code:RF-2010-2308451
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU di Bologna, Policlinico S.Orsola-Malpighi
    B.5.2Functional name of contact pointG.Montini,S.S.Neforologia Pediatric
    B.5.3 Address:
    B.5.3.1Street AddressVia Albertoni 15
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40138
    B.5.3.4CountryItaly
    B.5.4Telephone number00390516364617
    B.5.5Fax number0039051636617
    B.5.6E-mailgiovanni.montini@aosp.bo.it
    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.2.1.2Country 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 oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNAMOXICILLIN
    D.3.9.1CAS number 26787-78-0
    D.3.9.4EV Substance CodeSUB05481MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLAVULANIC ACID
    D.3.9.1CAS number 58001-44-8
    D.3.9.4EV Substance CodeSUB06642MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11
    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 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.2.1.2Country 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 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 INNNITROFURANTOIN
    D.3.9.1CAS number 67-20-9
    D.3.9.3Other descriptive nameNITROFURANTOIN
    D.3.9.4EV Substance CodeSUB09326MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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.2.1.2Country 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 Granules for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNCEFIXIME
    D.3.9.1CAS number 79350-37-1
    D.3.9.3Other descriptive nameCEFIXIME
    D.3.9.4EV Substance CodeSUB07395MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 4
    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.2.1.2Country 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 Oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNSULFAMETHOXAZOLE
    D.3.9.1CAS number 723-46-6
    D.3.9.4EV Substance CodeSUB10711MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIMETHOPRIM
    D.3.9.3Other descriptive nameTRIMETHOPRIM
    D.3.9.4EV Substance CodeSUB11310MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    evaluation of the effectiveness of antimicrobial prophylaxis in infants with vesico-ureteral reflux grade III-V, started before the first symptomatic infection
    Valutazione dell’efficacia della profilassi antibiotica iniziata in lattanti con reflusso vescico-ureterale di III-V, iniziata prima dell’insorgenza della prima infezione urinaria sintomatica
    E.1.1.1Medical condition in easily understood language
    evaluation of the effectiveness of antimicrobial prophylaxis in infants with vesico-ureteral reflux grade III-V, started before the first symptomatic infection
    Valutazione dell’efficacia della profilassi antibiotica iniziata in lattanti con reflusso vescico-ureterale di III-V, iniziata prima dell’insorgenza della prima infezione urinaria sintomatica
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10047371
    E.1.2Term Vesicoureteral reflux
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is the evaluation of the effectiveness of antimicrobial prophylaxis in infants with vesico-ureteral reflux grade III-V, started before the first symptomatic infection.
    Valutazione dell’efficacia della profilassi antibiotica iniziata in lattanti con reflusso vescico-ureterale di III-V, iniziata prima dell’insorgenza della prima infezione urinaria sintomatica.
    E.2.2Secondary objectives of the trial
    The secondary objectives are the evaluation of
    1. the role of symptomatic and febrile UTIs on the appearance and progression of kidney damage and development of renal function;
    2. the natural history of renal function of paediatric patients with congenital kidney or urinary tract anomalies during the first 5 years of life;
    3. the natural evolution of vesico-ureteral reflux during the first 5 years of life and its correlation with UTIs, renal scars and impairment of renal function;
    4. the hypothetic role of prophylactic antibiotic therapy during the first months of life on BMI at 2 and 5 years of age.
    1. Valutazione del ruolo delle infezioni sintomatiche e febbrili delle vie urinarie nell’insorgenza e nella progressione del danno renale e nell’evoluzione della funzione renale.

    2. Valutazione della storia naturale della funzione renale in pazienti pediatrici con anomalie congenite del rene o delle vie urinarie nei primi 5 anni di vita.

    3. Valutazione dell’evoluzione naturale del reflusso vescico-ureterale durante i primi 5 anni di vita e della sua correlazione con l’insorgenza di Infezioni delle vie Urinarie, cicatrici renali o peggioramento della funzione renale.

    4. Valutazione dell’ipotetica influenza di una terapia antibiotica somministrata nei primi mesi di vita sul Body Mass Index (BMI) valutato al 2° e al 5° anno di vita
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Age between 1 and 4 months
    b. Gestational age > 35 weeks
    c. Glomerular filtration rate (calculated according to Schwartz) > 15 ml/min/1.73 m2 at three months of age
    d. No previous symptomatic UTI
    e. Imaging Diagnostic work-up completed and presence of grade III to V vesico-ureteral reflux
    f. Informed consent of parents
    a. Età compresa tra 1 e 4 mesi all’arruolamento.
    b. Eta gestazionale > 35 settimane.
    c. Filtrato glomerulare (GFR) calcolato secondo la formula di Schwartz > 15 ml/min/1.73 m2 a 3 mesi di età.
    d. Non precedenti Infezioni delle vie Urinarie Sintomatiche.
    e. Completamento del work-up radiologico di screening e presenza di reflusso vescico-ureterale di 3°-5° grado.
    f. Consenso informato firmato dai genitori.
    E.4Principal exclusion criteria
    a. Age <1 and >4 months
    b. Gestational age < 35 weeks
    c. Glomerular filtration rate (calculated according to Schwartz) < 15 ml/min/1.73 m2 at three months of age
    d. Patients with neurogenic bladder, myelomeningocele, uretero-pelvic junction and/or uretero-vescico junction obstruction, or other malformations leading to potential voiding disturbances, apart from urethral valves
    e. Patients with no or low grade reflux (grade I and II).
    f. Hypersensitivity to the all the utilized antimicrobial agent
    g. Children with serious clinical conditions which, according to the investigator, prevent them from being included in the study cohort.
    h. Use of experimental drugs in the month previous to the beginning of the study
    i. Children unable to follow the established protocol procedures or whose parents are unable to sign the informed consent.
    a. Età <1 o >4 mesi.
    b. Età gestazionale < 35 weeks.
    c. Filtrato glomerulare (GFR) calcolato secondo la formula di Schwartz < 15 ml/min/1.73 m2 a 3 mesi di età.
    d. Pazienti con vescica neurologica, mielomeningocele, stenosi del giunto pielo-ureterale, ostruzione della giunzione uretero-vescicale, o altre malformazioni potenzialmente correlate all’insorgenza di disturbi minzionali, eccetto le valvole dell’uretra.
    e. Pazienti senza reflusso vescico-ureterale o con reflusso vescico-ureterale di 1°-2° grado.
    f. Ipersensibilità a tutti i principi attivi previsti dal protocollo
    g. Bambini in condizioni cliniche severe che, a parere dello sperimentatore, non permettano l’arruolamento nella coorte dello studio.
    h. L’uso di farmaci nel mese precedente l’arruolamento nello studio.
    i. Bambini non in grado di seguire le procedure stabilite dal protocollo o bambini con genitori incapaci di firmare il consenso informato.
    E.5 End points
    E.5.1Primary end point(s)
    symptomatic urinary tract infection rate during the 24-month observation period.

    tasso di infezioni sintomatiche delle vie urinarie durante i 24 mesi di trattamento/osservazione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    E.5.2Secondary end point(s)
    number of febrile UTIs and of new renal scars (DMSA scan) at the 2 and 5 years follow-up in relation to the development of renal function (creatinine and Cystatin C plasma values, eGFR), hypertension (blood pressure >95th%ile per age, sex and height) and/or proteinuria (protein/creatinine), anatomical growth (renal length) of the kidneys at 2 and 5 years follow-up, evaluation of the natural course of renal function for hypo-dysplastic kidneys during the first 5 years of life
    Gli END POINT SECONDARI sono le infezioni urinarie febbrili, il numero di cicatrici renali alla scintigrafia con DMSA di controllo dopo 2 anni; l’evoluzione della funzionalità renale, l’ipertensione arteriosa e/o la proteinuria, la valutazione della storia naturale della funzione renale per i reni ipo-displasici durante i primi 5 anni di vita e la valutazione del Body Mass Index (BMI) a 2 e a 5 anni di età
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 months
    60 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    nessun farmaco, solo sorveglianza clinica
    NO drug, normal clinical surveillance
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Belgium
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Lithuania
    Poland
    Portugal
    Serbia
    Switzerland
    Turkey
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    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: 436
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 436
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    infants, Consent should be obtained by parents/tutor
    minorenni, Consenso informato dovrà essere ottenuto dai genitori /tutor
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 436
    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)
    according to the clinical conditions will be guaranteed clinical care, and eventualy therapeutic, more appropriate
    in base alle condizioni cliniche verrà garantita l'assistenza clinica, ed eventualmente terapeutica, più appropriata
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation ESCAPE group
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-16
    P. End of Trial
    P.End of Trial StatusOngoing
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