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    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-001406-17
    Sponsor's Protocol Code Number:48009
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-08-05
    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 number2014-001406-17
    A.3Full title of the trial
    Ventilator Associated Pneumonia: addition of Tobramycin Inhalation antibiotic treatment to standard IV antibiotic treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pneumonia obtained by mechanical ventilation: investigation whether adding inhalation antibiotics with tobramycin to standard intravenous antibiotic treatment is better than intravenous antibiotic treatment alone
    A.4.1Sponsor's protocol code number48009
    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 SponsorErasmus MC
    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 supportErasmus MC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointresearch longziekten
    B.5.3 Address:
    B.5.3.1Street AddressPostbus 2040
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3000 Ca
    B.5.3.4CountryNetherlands
    B.5.6E-mailresearch.longziekten@erasmusmc.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 Bramitob
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi
    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 nameBramitob
    D.3.2Product code 033841
    D.3.4Pharmaceutical form Inhalation vapour, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation vapour, solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ICU patients with ventilator-associated pneumonia
    E.1.1.1Medical condition in easily understood language
    patients who develop a pneumonia when receiving mechanical ventilation
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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
    Does addition of inhalation tobramycin to standard IV treatment result in a higher clinical cure rate than standard IV antibiotic treatment alone in patients with ventilator-associated pneumonia.
    The initial response to treatment will be evaluated after 3 days of antimicrobial treatment.

    E.2.2Secondary objectives of the trial
    Does addition of inhalation tobramycin to standard IV treatment result in a lower mortality and shorter length of stay than standard IV antibiotic treatment alone in patients with ventilator-associated pneumonia.

    Does addition of inhalation tobramycin to standard IV treatment result in an improved bacterial eradication rate than standard IV antibiotic treatment alone in patients with ventilator-associated pneumonia.

    In case of non-response at day 4, what are the causes of non-response?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The clinical suspicion of pneumonia is based on the ATS criteria:
    - new or progressive radiologic pulmonary infiltrate
    Together with at least two of the following three criteria:
    - temperature >38°C
    - leukocytosis >12,000/mm3 or leucopenia <4,000/mm3
    - purulent respiratory secretions
    E.4Principal exclusion criteria
    patients with allergy to tobramycin; pregnancy; expected to die within 72
    hours after enrollment
    E.5 End points
    E.5.1Primary end point(s)
    Nonresponse is considered when at least one of the following criteria is present:
    (1) No improvement of the arterial O2 tension to inspired O2 fraction ratio
    (2) Persistence of fever (≥38°C) or hypothermia (<35.5°C) together with purulent
    respiratory secretions
    (3) increase in the pulmonary infiltrates on chest radiograph of greater than or equal to 50%
    (4) occurrence of septic shock or multiple organ dysfunction syndrome, defined as three or more organ system failures not present on Day 1
    E.5.1.1Timepoint(s) of evaluation of this end point
    The initial response to treatment will be evaluated after 3 days of antimicrobial treatment.
    E.5.2Secondary end point(s)
    - 30-day and 90- day mortality rate
    - ICU survival
    - Number of days without mechanical ventilation
    - length of stay
    - discharge from the ICU
    - duration of mechanical ventilation
    - adverse events
    - day of normalisation of CRP, procalcitonin (PCT) and chest X-ray
    - eradication of pathogens (especially pseudomonas)
    - Clinical Pulmonary Infectious Score (31); APACHE II score; multiple organ dysfunction score (MODS)
    - Cytokine response
    - Causes of nonresponse. In patients with initial nonresponse to treatment, cultures of respiratory samples and blood will be obtained again, and the empiric antimicrobial treatment will be revised
    E.5.2.1Timepoint(s) of evaluation of this end point
    The initial response to treatment will be evaluated after 3 days of antimicrobial treatment.
    and at day 8, 14, discharge ICU, discharge hospital, Day 30, Day 90
    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 No
    E.6.5Efficacy Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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
    some subjects will be sedated on mechanical ventilation and will not be able to give consent prior to the study.
    In these cases we will ask close family (next of kin); at a later stage we ask for consent from the patient self
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 84
    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 Decision2014-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-21
    P. End of Trial
    P.End of Trial StatusOngoing
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