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    Summary
    EudraCT Number:2015-001239-19
    Sponsor's Protocol Code Number:PHRN14-PFD-CAPE_COD
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-07-29
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-001239-19
    A.3Full title of the trial
    Effects of low-dose corticosteroids on survival of severe Community-Acquired Pneumonia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Community-Acquired Pneumonia : Evaluation of COrticosteroiDs (CAPE COD)
    A.3.2Name or abbreviated title of the trial where available
    CAPE COD
    A.4.1Sponsor's protocol code numberPHRN14-PFD-CAPE_COD
    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 SponsorCHRU de TOURS
    B.1.3.4CountryFrance
    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 supportCHRU de TOURS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de TOURS
    B.5.2Functional name of contact pointClinical Research Asssociate
    B.5.3 Address:
    B.5.3.1Street AddressCellule Promotion et Contrôle Qualité, DRCI - 2, boulevard Tonnellé
    B.5.3.2Town/ cityTOURS
    B.5.3.3Post code37044
    B.5.3.4CountryFrance
    B.5.4Telephone number+33247474632
    B.5.5Fax number+33247474662
    B.5.6E-mailyoann.desvignes@med.univ-tours.fr
    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 HYDROCORTISONE UPJOHN 100 mg for injection
    D.2.1.1.2Name of the Marketing Authorisation holderSERB
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameHYDROCORTISONE
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPParenteral use (Noncurrent)
    Intravenous drip use (Noncurrent)
    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 placeboPowder and solvent for solution for infusion
    D.8.4Route of administration of the placeboIntravenous drip use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe community-acquired pneumonia
    E.1.1.1Medical condition in easily understood language
    Severe community-acquired pneumonia
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10010120
    E.1.2Term Community acquired pneumonia
    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
    Demonstrate that hydrocortisone started during the first 24 hours following the occurrence of the first severity criterion and administered for four to seven day at full dose (and then tapered for another four or seven days period) to patients admitted to the ICU for severe CAP could improve the D-28 survival when compared to placebo.
    E.2.2Secondary objectives of the trial
    • Demonstrate that hydrocortisone could decrease:
    - The need for intubation (for patients not-intubated at inclusion)
    - The need for non-invasive ventilation (for patients not-ventilated at inclusion)
    - The length of mechanical ventilation
    - The need for vasopressors
    - The vasopressors length of administration
    - The ICU and/or intermediate care unit length-of-stay (LOS)
    - The D-90 mortality
    - The level/activity of inflammation biomarkers

    • Demonstrate that hydrocortisone could improve:
    - The oxygenation parameters
    - The level of organ dysfunctions
    - The survivors quality of life

    • Evaluate the side-effects potentially linked to CTx administration in this clinical setting
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥ 18 years
    • Admission to an ICU or intermediate care unit participating to the trial
    • Diagnosis of CAP suggested by at least two of the following : cough, purulent sputum, chest pain and dyspnea
    • Focal shadowing/infiltrate on chest X-ray or CT-scan
    • Diagnosis of CAP during the 48 hours post-hospital admission
    • Study drug infusion initiated no longer than 24 hours post first severity criterion
    • Severity defined by at least one of the following :
    - Pneumonia Severity Index (PSI) > 130 (Fine class V)
    - Patient placed on mechanical ventilation (invasive or not) for acute respiratory failure, with a PEEP level of 5 cm of water or more
    - Patient treated by high-flow oxygen therapy with a FiO2 of 50% or more and a P/F ratio lower than 200
    • Patient already treated by antibiotics (at least one dose)
    • Patients affiliated to social security scheme (“Sécurité sociale”)
    • Informed consent signed by the patient, its relatives or emergency procedure
    E.4Principal exclusion criteria
    • Patient treated by vasopressors for septic shock at the time of inclusion
    • Clinical history suggesting of aspiration of gastric content
    • Patient treated by invasive mechanical ventilation within 14 days before current hospital admission
    • Patient treated by antibiotics for a respiratory infection for more than five days at the admission to the hospital (except if a pathogen resistant to this antibiotics is isolated)
    • History of cystic fibrosis
    • Post-obstructive pneumonia
    • Patients in which rapid PCR-test is positive for flu
    • Active tuberculosis or fungal infection
    • Active viral hepatitis or active infection with herpes viruses
    • Decision of withholding mechanical ventilation or endotracheal intubation
    • Patient needing anti-inflammatory corticosteroids or substitutive hydrocortisone for any reason.
    • Patients under treatment by more than 15 mg/d of prednisone (or equivalent) for more than 30 days
    • Patient already enrolled in another drug trial
    • Pregnant or breastfeeding woman
    • Patient on judicial protection
    E.5 End points
    E.5.1Primary end point(s)
    D28 all causes mortality
    E.5.1.1Timepoint(s) of evaluation of this end point
    D28
    E.5.2Secondary end point(s)
    • In patients non-invasively ventilated at inclusion, proportion of patients needing endotracheal intubation
    • In patients non-ventilated at inclusion, proportion of patients requiring non-invasive ventilation (NIV) and proportion of patients needing endotracheal intubation
    • D28 ventilator-free-days. This outcome will be assessed applying the following rules:
    - The period of interest will begin at the randomization date
    - Patients who die before day 28 will be affected a 0 value
    - Days between two mechanical ventilation episodes will be taken into account
    - A successful extubation will be defined as a spontaneous breathing 48h after extubation
    • Number of patients with vasopressor therapy initiation from inclusion to D28
    • D28 vasopressor-free-days. This outcome will be assessed applying the following rules:
    - The period of interest will begin at the randomization date
    - Patients who die before day 28 will be affected a 0 value
    - Days between two vasoconstrictor-therapy episodes will be taken into account
    • ICU and/or intermediate care unit LOS
    • All-causes mortality at D90
    • SF-36 Health Survey at D90
    • Biomarkers : procalcitonin, C-reactive protein and plasmatic concentration of pro-inflammatory cytokines (IL-6, IL-20, IL-22, IL-22BP, HBD2, TNF alpha) at baseline, D3 and D7
    • P/F ratio measured daily from D1 to D7, at the end of treatment, at the end of ICU-stay and/or D28
    • SOFA calculated daily from D1 to D7, at the end of treatment, at the end of ICU-stay and/or D28
    • Proportion of patients experiencing secondary infection during their ICU-stay
    • Proportion of patients experiencing gastrointestinal bleeding during their ICU-stay
    • Daily amount of insulin administered to the patient from D1 to D7
    • Weight-gain from baseline to D7
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, D1 to D7, at the end of treatment, at the end of ICU-stay, D28, D90
    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 Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 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 concerned22
    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
    LVLS
    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 months3
    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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 600
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects with a condition which makes them incapable of giving consent personally and who need urgent care. When a subject is no longer incapacitated, informed consent to continue participation will be obtained from the subject at that time
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1200
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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