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    Summary
    EudraCT Number:2007-004646-33
    Sponsor's Protocol Code Number:DORINOS3008
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-03-05
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-004646-33
    A.3Full title of the trial
    A Prospective, Randomized, Double-Blind, Double-Dummy, Multicenter
    Study to Assess the Safety and Efficacy of Doripenem Compared With
    Imipenem in the Treatment of Subjects with Ventilator-Associated Pneumonia
    A.4.1Sponsor's protocol code numberDORINOS3008
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 Finibax
    D.2.1.1.2Name of the Marketing Authorisation holderShinogi & Company
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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.3.2Product code JNJ-38174942
    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 monohydrate
    D.3.9.1CAS number 364622-82-2
    D.3.9.2Current sponsor codeJNJ-38174942
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Tienam IV 500mg/500 mg Powder for Solution for Infusion
    D.2.1.1.2Name of the Marketing Authorisation holderMDS Polska Sp.Z.o.o.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 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 INNImipenem
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.3.10 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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 <Manually entered code. Term in E.1.1>
    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 to demonstrate the noninferiority of a 7-day course
    of doripenem to a 10-day course of imipenem with respect to the clinical
    cure rate at the EOT visit in clinically evaluable subjects with VAP.
    E.2.2Secondary objectives of the trial
    Demonstrate:
    •noninferiority of doripenem to imipenem with respect to the clinical cure rate at the EOT visit in ME subjects
    •superiority of doripenem relative to imipenem with regard to clinical cure rate at EOT in ME subjects from whom:
    -P. aeruginosa are isolated from lower respiratory tract (LRT) specimen at
    baseline
    -at least one of the following specific serious gram-negative organisms is isolated at baseline:Enterobacteriaceae, P. aeruginosa, and Acinetobacter spp
    •that baseline and emergent resistance at an MIC level of
    ≥8 μg/mL to study drug received is lower in P. aeruginosa to doripenem
    than imipenem
    •Explore:early markers of efficacy;relationship between the imipenem concentration over MIC with their clinical outcome;exposure-response relationships for doripenem microbiologic and their clinical outcomes using PK/PD modeling;medical resource utilization
    •Evaluate the safety of 1 gram dose of doripenem
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ·Men or women 18 years of age or older
    ·Have new or progressive radiographic infiltrates consistent with VAP that is not related to cardiac or other disease processes taken within 12 hours before screening. A CT scan may be required to evaluate parenchymal disease if the chest X-ray is not sufficiently interpretable
    ·Have at least 1 of the following:
    –Fever (in the absence of antipyretics): a rectal temperature greater than 39°C OR an increase in core temperature of greater than 1°C
    –Hypothermia, defined as a rectal/core body temperature of less than 35°C
    –Leukocytosis (WBC count ³10x109/L or ³15% immature neutrophils, regardless of the total peripheral white cell count; or leukopenia with total WBC count less than 4x109/L
    ·Have developed VAP and have been on mechanical ventilation for ³48 hours and on mechanical ventilation at the time of randomization. They may have been treated for VAP with antibiotics and have clinical deterioration associated with a probable new pathogen if they have been on a ventilator for >72 hours
    ·Have been hospitalized or been in a chronic care facility for a total of 5 or more days within the last 90 days
    ·Have a baseline CPIS of ³6
    ·Have an APACHE II Score of >8 and <35
    ·Have microbiologically suitable LRT sample available (BAL/mini BAL)within 12 hours
    before screening
    ·Women must be postmenopausal (for at least 1 year), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent (at the discretion of the investigator), or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel], male partner sterilization) before entry and must agree to continue to use the same method of contraception throughout the study; have a negative serum beta-human chorionic gonadotropin (b hCG] or urine pregnancy test at screening (depending on local regulations)
    ·Willing to adhere to the prohibitions and restrictions specified in this protocol
    ·Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Consent may be given for unconscious/incapacitated subjects by a legally authorized representative, according to local regulatory and ethical practice using a subject information sheet and informed consent form approved by the responsible Ethics Committee. When a subject is no longer incapacitated, informed consent will be obtained from the subject at that time.
    E.4Principal exclusion criteria
    ·Received antibiotics for this episode of VAP for >24 hours before randomization. Subjects will not be excluded if their prior antibiotic therapy has been given for more than 48 hours, are failing therapy by clinical assessments and the antibiotic has not been changed within the 24-hour period before the first dose of i.v. study drug is given.
    ·Known presence at baseline of only MRSA or Stenotrophomonas infection
    ·Acute respiratory distress syndrome (ARDS defined by diffuse radiographic infiltrates and PaO2 to fraction of inspired oxygen [FiO2] ratio <200)

    ·Has any of the following conditions that interfere with the assessment or interpretation of the diagnosis or response to therapy:
    –Chest trauma with lung contusion or flail chest. A CT scan may be required to
    distinguish pneumonia from severe lung contusion on the chest X-ray
    –Pleural effusion(s) requiring drainage or empyema
    –Lung cancer-primary or secondary within the last 2 years
    –Chronic bronchitis with an exacerbation within the last 30 days
    –Bronchiectasis
    –Lung abscess(s)
    –Anatomical bronchial obstruction
    –Respiratory tuberculosis on treatment
    –Suspected atypical pneumonia
    –Chemical pneumonitis (e.g., aspiration of gastric contents, inhalation injury)
    –Cystic fibrosis
    –Congestive Heart Failure as noted by the New York Heart Association Classification IV
    –Active seizure disorder within the last 2 year or brain injury such that imipenem would not be administered to the subject in usual practice
    –Severe burns to greater than 15% of the body
    –Pre-morbid evidence of stigmata of severe and chronic liver disease indicating cirrhosis in the opinion of the investigator

    ·History of severe impairment of renal function (i.e., a calculated creatinine clearance (CLCR) of less than 10 mL/minute) requiring continuous renal replacement therapy (CRRT), peritoneal dialysis, hemodialysis, hemofiltration, or oliguria (less than 20 mL urine output per hour over 24 hours)
    ·History of immunocompromising illness, acquired immunodeficiency syndrome (AIDS), or human immunodeficiency virus (HIV) with a CD4 count less than 200 cells/mL within the past 6 months, antiretroviral therapy within the last 60 days, organ (including bone marrow) transplant recipients, hematologic malignancy, and use of immunosuppressive therapy within 60 days, or use of high-dose corticosteroids (e.g greater than 40 mg of systemic prednisone or equivalent per day) in the last 2 weeks. History of rapid tapering steroids completed over 2 weeks before enrollment will be allowed.
    ·History of any rapidly progressing disease or immediately life-threatening illness (including acute hepatic failure and septic shock. Shock is defined as a systolic blood pressure less than 90 mmHg for greater than 2 hours, despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents.)
    ·History of hypersensitivity reactions to carbapenems, penicillins, other b lactam antibiotics, or b lactamase inhibitors (subjects with a history of mild skin rash, documented not to have been caused by previous b lactam use are permitted to enroll)
    ·Have previously received doripenem
    ·Have previously received meropenem or imipenem in the last week
    ·Have any other known or suspected condition that may jeopardize adherence to protocol requirements or interpretation of adverse events
    ·Suspicion of pulmonary edema as a cause of the acute illness
    ·Hematocrit of less than 22% or hemoglobin of less than 7 g/dL
    ·Neutropenia with absolute neutrophil count of less than 1,000 cell/mm3. Subjects with neutrophil counts as low as 500 cells/mm3 are permitted if the reduction is due to the acute infection process.
    ·Platelet count of less than 50,000 cells/mm3
    ·Current use of probenecid or valproic acid
    ·Are hospitalized involuntarily
    ·Have received an experimental medication or used an experimental medical device within 30 days.Subjects in clinical studies for approved products will not be excluded.
    ·Is breast-feeding
    ·Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint
    ·Clinical cure rate at the EOT visit in clinically evaluable subjects.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Microbiologic Efficacy Assessments
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 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
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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 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.1.3Elderly (>=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 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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 524
    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 Decision2008-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
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