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    The EU Clinical Trials Register currently displays   43927   clinical trials with a EudraCT protocol, of which   7307   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:2007-005633-10
    Sponsor's Protocol Code Number:DORI INI 2002
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-07
    Trial results View 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 number2007-005633-10
    A.3Full title of the trial
    A Phase 2, Open-Label, Non-Comparative Study of Doripenem in the Treatment of Nosocomial and Ventilator-Associated Pneumonia in Hospitals where Pseudomonas aeruginosa may be a Prevalent Pathogen.
    A.4.1Sponsor's protocol code numberDORI INI 2002
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorORTHO MCNEIL JANSSEN SCIENTIFIC AFFAIRS, LLC
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 organisation
    B.5.2Functional name of contact point
    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 DORIBAX
    D.2.1.1.2Name of the Marketing Authorisation holderJohnson & Johnson Pharmaceutical Research and Development (J&JPRD)
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameDoripenem
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDoripenem
    D.3.9.1CAS number 364622-82-2
    D.3.9.2Current sponsor codeJNJ-38174942-ZAF (S-4661)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Nosocomial and Ventilator-Associated Pneumonia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10065153
    E.1.2Term Ventilator associated pneumonia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052596
    E.1.2Term Nosocomial pneumonia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate clinical response and safety of a new carbapenem in the treatment of subjects with nosocomial pneumonia (NP) or ventilator-associated pneumonia (VAP) in hospitals where Pseudomonas aeruginosa may be a prevalent pathogen.
    E.2.2Secondary objectives of the trial
    Other objectives are to gain experience with doripenem as part of a
    combination antibacterial regimen and to collect medical resource utilization
    data.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Microbiological samples (respiratory secretions) suitable for culture
    and microscopy (e.g., obtained via BAL, PSB, mini-BAL, deep
    suction via endotracheal tube [including through a tracheostomy tube],
    nasotracheal aspiration specimen or suitable expectorated sputum).
    Note: Suitable specimens from expectorated samples are defined as having
    </= to 10 squamous epithelial cells and >/= 25 leukocytes per low power field
    (10 x objective).
    If the initial collection of respiratory secretions is obtained via
    bronchoscope (BAL, PSB) or via mini-BAL (done using a
    prepackaged, commercially available telescoping catheter, passed
    through the endotracheal tube), then a sample of respiratory secretions
    should be obtained simultaneously via deep suctioning through the
    endotracheal tube or tracheostomy tube. This will allow for a more
    accurate comparison between a sample obtained at study entry and the
    required subsequent respiratory samples.

    2. CPIS >/= 6 at baseline in subjects with VAP.

    3. APACHE II score >/= 8 and </= 35.

    4. Subjects suffering from NP or VAP defined as follows:
    Nosocomial Pneumonia
    (Subjects must have a, b, and c)
    a) Clinical signs and symptoms of de novo pneumonia after >/= 5 days of
    hospitalization or residence in a chronic care facility. Clinical signs
    and symptoms of pneumonia with AT LEAST 2 of the following
    criteria:
    • New onset of purulent sputum production or respiratory secretions or a
    worsening in character of sputum or respiratory secretions already
    present.
    • Tachypnea (respiratory rate >/= 20/minute), particularly if progressive in
    nature.
    • De novo hypoxemia with a PO2 </= 60 mmHg while subject is breathing on
    room air, as determined by arterial blood gas.
    b) New radiographic infiltrates (not related to another disease process).
    c) Fever or leukocytosis/leukopenia consistent with a diagnosis of
    pneumonia with AT LEAST 1 of the following at evaluation:
    • Leukocytosis defined as AT LEAST 1 of the following:
    Hospital baseline WBC was normal, but subsequently increased to
    >/=10,500.
    Exception: If hospital baseline WBC was significantly above or below
    10,500, an increase of at least 25% from the baseline WBC will also
    constitute leukocytosis.
    >/= 10% immature neutrophils (bands).
    • Leukopenia defined as </=4,500.
    • Fever or documentation of a history of fever ([in the absence of
    antipyretics], increase in core temperature of >1°C OR a rectal or oral
    temperature >38°C, a tympanic temperature >38.4°C OR hypothermia,
    defined as a rectal/core body temperature of <35°C) within the past
    24 hours.
    E.4Principal exclusion criteria
    1. Known or suspected severe renal impairment, (i.e., a calculated
    creatinine clearance [CrCl] <10 mL/minute) or oliguria (less than 20
    mL urine output per hour over 24 hours unresponsive to fluid
    challenge), or requiring peritoneal dialysis, hemodialysis, or
    hemofiltration.

    2. Known or suspected hepatic dysfunction based on history or previous
    laboratory values during hospitalization (total bilirubin, or alanine
    aminotransferase [ALT], or aspartate aminotransferase [AST] >/= 3 times
    upper limit of the normal range [ULN]). Contact medical monitor if
    upper limit of normal is >/= 3 times and subject does not have any
    underlying hepatic disease or disorder.

    3. Subjects who have a history of or who are at high risk for seizure
    disorder or stroke who are not on preventative medication or therapy.

    4. Known to be HIV-positive with CD4 counts of </= 0.2x10(to the power 9) /L
    (</=200 cells/mm3) observed within the last 6 months prior to study
    entry. (Subjects with HIV and CD4 counts of >0.2x10(to the power 9) /L
    [>200 cells/mm3] may be included.)

    5. Presence of myelosuppression or neutropenia (ANC <0.5 x 10(to the power 9) /L
    [<500 PMNs/mm3], unless recovering from chemotherapy and
    expected to exceed 500 PMNs/mm3 in 24 hours), severe anemia
    (hemoglobin <6.5 g/dL, not due to acute blood loss) or severe
    thrombocytopenia (<49.9 x 10(to the power 9) /L) based on CBC results.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical response (clinical cure, failure, unable to evaluate), as the primary endpoint, will be assessed at the TOC assessment. Pathogen burden will be tracked and correlated with clinical response.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.5.1Number of sites anticipated in the EEA5
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-12-07. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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
    Consent may be given for unconscious/incapacitated subjects by their next of kin, guardian, or legal representative according to local regulatory/ethical practice using a subject information sheet/informed consent form approved by responsible EC.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 1000
    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 Decision2008-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-25
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