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    Summary
    EudraCT Number:2014-001546-25
    Sponsor's Protocol Code Number:NL48960.029.14
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-11-19
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-001546-25
    A.3Full title of the trial
    Short versus extended antibiotic treatment with a carbapenem for high-risk febrile neutropenia in hematology patients with Fever of Unknown Origin: a randomized multicenter open-label non-inferiority trial.
    Korte versus lange behandeling met een carbapenem voor onverklaarde koorts tijdens hoog risico neutropenie bij hematologische patiënten: een gerandomiseerde non-inferiority studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Short versus extended antibiotic treatment for fever during low white blood cell counts in hematology patients with fever of unknown origin.
    Korte versus lange antibioticabehandeling voor onverklaarde koorts tijdens lage witte bloedcelllen bij hematologische patienten.
    A.3.2Name or abbreviated title of the trial where available
    SHORT-trial
    A.4.1Sponsor's protocol code numberNL48960.029.14
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02149329
    A.5.4Other Identifiers
    Name:Dutch Trial RegistrationNumber:NTR3675
    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 SponsorVU University Medical Center
    B.1.3.4CountryNetherlands
    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 supportZonMW
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportFonds Nuts Ohra
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Medical Center
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31204441388
    B.5.6E-mailshort@vumc.nl
    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 imipenem-cilastatine
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameimipenem / cilastatine
    D.3.2Product code RVG 101614
    D.3.4Pharmaceutical form Concentrate 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 INNIMIPENEM
    D.3.9.1CAS number 64221-86-9
    D.3.9.4EV Substance CodeSUB08151MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCilastatin
    D.3.9.1CAS number 82009-34-5
    D.3.9.3Other descriptive nameCILASTATIN
    D.3.9.4EV Substance CodeSUB06264MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeup to
    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 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 Meropenem
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namemeropenem
    D.3.2Product code RVG 105155
    D.3.4Pharmaceutical form 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.3.9.1CAS number 96036-03-2
    D.3.9.3Other descriptive nameMEROPENEM
    D.3.9.4EV Substance CodeSUB08778MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number3
    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
    Febrile neutropenia
    Neutropene koorts
    E.1.1.1Medical condition in easily understood language
    Fever during low white blood cell counts
    Koorts gedurende lage witte bloedcelgetallen.
    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 19.1
    E.1.2Level PT
    E.1.2Classification code 10063581
    E.1.2Term Stem cell transplant
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10002969
    E.1.2Term Aplastic anemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10003999
    E.1.2Term Bacteremia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10007810
    E.1.2Term Catheter related infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10028566
    E.1.2Term Myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10062957
    E.1.2Term Catheter bacteraemia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10025310
    E.1.2Term Lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10024329
    E.1.2Term Leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10056520
    E.1.2Term Catheter site infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10016288
    E.1.2Term Febrile neutropenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess if short antibiotic treatment (3x24 hours) with an anti-pseudomonal carbapenem (imipenem-cilastatin or meropenem) is safe (NON-INFERIOR) with regard to treatment failure in comparison with extended treatment (at least 9x24hours) of high-risk febrile neutropenia in hematology patients receiving standard antimicrobial prophylaxis.
    Te onderzoeken of korte antibiotische behandeling (gedurende 3x24 uur) met een anti-pseudomonale carbapenem (imipenem-cilastine of meropenem) veilig (non-inferieur) is ten aanzien van het falen van de behandeling in vergelijking met lange behandeling (gedurende tenminste 9x24uur) bij hoog-risico neutropene koorts bij hematologische patiënten die standaard antimicrobiële profylaxe krijgen.
    E.2.2Secondary objectives of the trial
    To assess if short antibiotic treatment (3x24 hours) with an anti-pseudomonal carbapenem (imipenem-cilastatin or meropenem) is NON-INFERIOR in comparison with extended treatment (at least 9x24hours) of high-risk febrile neutropenia in hematology patients receiving standard antimicrobial prophylaxis with regard to:
    -Patient survival
    -Fever characteristics
    -Economic aspects
    -Antimicrobial use and its complications.
    -MASCC-score in relation to treatment failure
    -Mucositis as a risk factor for bacteremia (positive blood cultures) and treatment failure.
    Te onderzoeken of korte antibiotische behandeling (gedurende 3x24 uur) met een anti-pseudomonale carbapenem (imipenem-cilastine of meropenem) non-inferieur is in vergelijking met lange behandeling gedurende (ten minste 9 dagen) bij hoog-risico neutropene koorts bij hematologische patiënten die standaard antimicrobiële profylaxe krijgen ten aanzien van:
    -Overleving
    -Koortskarakteristieken
    -Economische aspecten
    -Antibioticagebruik en complicaties daarvan
    -MASCC-score in relatie tot therapiefalen.
    -Mucositis als risicofactor voor bacteriëmie (positieve bloedkweken) of falen van de behandeling.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Procalcitonin as a marker of antibiotic treatment success in febrile neutropenia with hematology patients receiving standard antimicrobial prophylaxis.
    2. Bacterial PCR as a marker for bacteremia and treatment failure in febrile neutropenia with hematology patients receiving standard antimicrobial prophylaxis.
    1. Procalcitonine als marker voor succesvolle antibiotische behandeling bij neutropene koorts bij hematologische patiënten die standaard antimicrobiëele prophylaxe krijgen.
    2. Bacteriële PCR als marker voor bacteriëmie en falen van de antibiotische behandeling bij hematologische patiënten met neutropene koorts die standaard antimicrobiële prophylaxe krijgen.
    E.3Principal inclusion criteria
    1.Patients with malignant hematological diseases being treated with cytotoxic chemotherapy or stem cell transplantation;
    2.High-risk neutropenia;
    3.Fever;
    4.Age 18 years or older;
    5.Written informed consent.
    1. Patiënten met een maligne hematologische ziekte die behandeld worden met cytotoxische chemotherapie of stamceltransplantatie;
    2. Hoog-risico neutropenia (geschatte neutropenie meer dan 7 dagen)
    3. Koorts
    4. Leeftijd van 18 jaar of ouder;
    5. Ondertekend informed consent
    E.4Principal exclusion criteria
    1.Contraindications to use of imipenem-cilastatin or meropenem such as allergy, previous severe side-effects or previous microbiological cultures with carbapenem-resistant microorganism(s).
    2.Corticosteroid use ≥10 mg per day prednisolone or equivalent for more than 3 consecutive days during the previous 7 days.
    3.Clinically or microbiologically documented infection.
    4.Symptoms of septic shock (systolic blood pressure <90 mm Hg unresponsive to fluid resuscitation and/or oliguria (urine production <500mL/day).
    5.Previous enrollment in this study during the same episode of neutropenia.
    6.Any critical illness for which Intensive Care Unit treatment is required.
    7.Legal incompetency
    1. Contraindicatie voor het gebruik van imipenem-cilastatine of meropenem zoals allergie, eerdere ernstige bijwerkingen of eerdere kweken met carbapenem-resistentie microganisme(n).
    2. Corticosteroidgebruik gedurende ten minste 3 aanééngesloten dagen in de afgelopen 7 dagen van 10mg of meer prednison of equivalent daarvan.
    3. Klinisch of microbiologisch vastgestelde infectie.
    4. Symptomen van septische shock (systolische bloeddruk <90mmHg niet reagerend op volumesuppletie en/of oligurie <500mL/dag).
    5. Eerdere deelname aan de studie tijdens dezelfde neutropene episode.
    6. Elke ernstige toestand waarvoor behandeling op de intensive care noodzakelijk is.
    7. Wilsonbekwaamheid.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the percentage of patients with failed treatment. Treatment failure is defined as the occurrence of any of the following events after 3x24hours of treatment with a carbapenem: -A clinically or microbiologically documented carbapenem-sensitive infection during treatment or within 7 days after discontinuation of carbapenem treatment. -Recurrence of fever after previous defervescence (tympanic temperature <38.0 °C during 24 hours) during treatment or within 7 days after discontinuation of carbapenem which is not attributable to administration of a blood product or to a drug reaction. o In case of clinical doubt if the fever is of infectious etiology, the recurrence of fever will be considered as failure. -The occurrence of death, ARDS/respiratory insufficiency, septic shock (systolic blood pressure <90mmHg and oliguria <500mL/day) due to any cause until the end of neutropenia. NOTE: The occurrence of fungal, viral or carbapenem-resistant (inherent or acquired) bacterial infections will not be considered as treatment failure. Examples of inherent carbapenem resistant bacteria include: E. faecium, commensal skin flora (ie. CNS), MRSA, Legionella spp., S. maltophilia, Bulkholderia cepacia, Chlamydia spp, Chlamydophilia spp., Mycoplasma spp., Ureoplasma urealyticum.

    Het primaire eindpunt is het percentage patiënte met falen van de behandeling. Falen wordt gedefinieerd als: 1.Ket vóórkomen van 1 van de volgende gebeurtenissen na 3x24uur en voor 9x24uur na start van de behandeling met een carbapenem: - Een klinisch of microbiologisch gedocumenteerde carbapenem-gevoelige infectie. - Het heroptreden van koorts na eerder koortsvrij te zijn geweest. In het geval dat er op basis van klinische gronden twijfel is of de oorzaak van de koorts infectieus is wordt dit als falen gezien. 2. Het optreden van dood, ARDS/ respiratoire insufficiëntie, septische shock (systolische bloeddruk <90mmHg an oligurie <500mL/dag)) door elke oorzaak tot het einde van de neutropenie. NB: Het optreden van fungale, virale of carbapenem-ongevoelige (inherent/verworven) bacteriële infectie wordt niet als therapiefalen gezien. Voorbeelden van inherent carabepenem-ongevoelige bacteriën zijn: E. faecium, commensale huidflora (ie. CNS), MRSA, Legionella spp., S. maltophilia, Bulkholderia cepacia, Chlamydia spp, Chlamydophilia spp., Mycoplasma spp., Ureoplasma urealyticum.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At day 9 after onset of treatment with a carbapenem
    Op dag 9 na de start van behandeling met een carbapenem
    E.5.2Secondary end point(s)
    1) Treatment failure (as defined by primary endpoint) from 9x24hours until 14x24 hours after onset of fever. 2) All-cause mortality from 3x24hours of treatment until the end of neutropenia. 3) Infection related mortality from 3x24hours of treatment until the end of neutropenia. 4) All-cause mortality within 30 days after recovery of neutropenia. 5) Infection related mortality within 30 days after recovery of neutropenia. 6) Treatment strategy failure, defined as the necessity to modify the antibacterial regimen after randomization other than for antibacterial prophylaxis. 7) The incidence and prevalence of all clinical or microbiological documented infections. fungal, viral, or carbapenem-resistant (inherent/acquired) infections until the end of neutropenia. 8) The incidence and prevalence of Clostridium difficile infections until 30 days after the end of neutropenia. 9) The length of hospitalization in days. 10) Time to defervescence. 11) The total number of febrile episodes during neutropenia. 12) Bacterial resistance in blood cultures and surveillance cultures (including minimal inhibitory concentrations (MIC)). 13) Candida spp. colonization in (surveillance) cultures; 14) Cost of antimicrobial therapy per admission 15) The percentage of patients with a MASCC-score ≥21 and treatment failure (defined as in primary endpoint) 16) The percentage of patients with mucositis and positive blood cultures or antibiotic treatment failure.
    1. Therapiefalen (zoals gedefinieerd als in het primaire eindpunt) vanaf 9 t/m 14x24uur na start van de behandeling met een carbapenem. 2.Alle mortaliteit tussen 3x24uur na start van de behandeling en einde van de neutropenie. 3. Infectie-gerelateerde mortaliteit 3x24uur na start van de behandeling en einde van de neutropenie. 4. Alle mortaliteit binnen 30 dagen na einde van de neutropenie. 5. Infectie-gerelateerde mortaliteit binnen 30 dagen na einde van de neutropenie. 6. Falen van de behandeling, gedefinieerd als de noodzaak om de antibiotische behandeling aan te passen na randomisatie, anders dan voor antibacteriële profylaxe. 7. De incidentie en prevalentie van alle klinisch en microbiologisch gedocumenteerde infecties. 8. Incidentie en prevalentie van infectie met Clostridium difficile tot 30 dagen na het einde van de neutropenie. 9. Opnameduur in dagen. 10. Tijd tot verdwijnen van koorts. 11. Totale aantal koortsepisodes in de neutropene periode. 12. Bacteriële resistentie in bloed- en surveillancekweken (inclusief MIC); 13. Kolonisatie van Candida spp in surveillancekweken; 14. Kosten van antimicrobiële therapie per opname. 15. Het percentage patiënten met een MASCC-score ≥21 en therapiefalen (gedefinieerd als het primaire eindpunt) 16. Het percentage patiënten met mucositis en positieve bloedkweken of falen van de antibiotische behandeling.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4,7-14: 30 days after the end of the neutropenic episode
    5,6: End of the neutropenic episode
    15: After the final patient has conpleted the end of the study (expected January 2017)
    1-4,7-14: 30 dagen na het einde van de neutropene episode.
    5,6: Einde van de neutropene episode
    15: Nadat de laatste patiënt de studie heeft voltooid (verwacht januari 2017)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Lange antibiotische behandelingsduur met dezelfde antibiotica.
    Extended antibiotic treatment with the same IMP
    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 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 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
    The sponsor (VUmc) may decide to terminate the study prematurely based on the following criteria:
    •There is evidence of an unacceptable risk for study patients (i.e. safety issue) based on a recommendation of the DSMB.
    •There is reason to conclude that it will not be possible to collect the data necessary to reach the study objectives and it is therefore not ethical to continue enrollment of more patients; for example insufficient enrollment that cannot be improved.
    De sponsor (VUmc) kan besluiten de studie voortijdig te beeindigen op basis van de volgende criteria:
    -Er zijn aanwijzingen voor onacceptabele risico's voor de deelnemende patiënten (bv veiligheid) gebaseerd op advies van de data safety and monitoring board (DSMB).
    -Er is reden om te concluderen dat het niet mogelijk is om de benodigde data te verzamelen om de studiedoelen te behalen en het daarom niet ethisch is om meer patienten te includeren.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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 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: 220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state240
    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)
    Participants will not be treated differently than standard care after end of participation.
    Deelnemers zullen niet anders worden behandeld dan de reguliere zorg, nadat de deelname aan dit onderzoek is voltooid.
    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 Decision2015-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-05
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