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    The EU Clinical Trials Register currently displays   43916   clinical trials with a EudraCT protocol, of which   7306   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2004-001730-17
    Sponsor's Protocol Code Number:BAP00307
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-11-22
    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 ConcernedUK - MHRA
    A.2EudraCT number2004-001730-17
    A.3Full title of the trial
    A Phase 3, Randomized Double-Blind Study of Ceftobiprole Medocaril Versus Linezolid Plus Ceftazidime in the Treatment of Nosocomial Pneumonia
    A.3.2Name or abbreviated title of the trial where available
    CHOPIN-2
    A.4.1Sponsor's protocol code numberBAP00307
    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 SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
    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 Information not present in EudraCT
    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 nameCeftobiprole
    D.3.2Product code BAL5788 (Laboratory Code)
    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 INNCeftobiprole medocaril
    D.3.9.1CAS number 252188-71-9
    D.3.9.2Current sponsor codeBAL5788
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Zyvoxid
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 INNLinezolid
    D.3.9.1CAS number 165800-03-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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: 3
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Biotum
    D.2.1.1.2Name of the Marketing Authorisation holderBioton Co. Ltd / Poland
    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 INNCeftazidime
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Nosocomial Pneumonia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 5.2
    E.1.2Level LLT
    E.1.2Classification code 10052596
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the noninferiority of ceftobiprole plus placebo compared with linezolid plus ceftazidime with respect to the clinical cure rate in subjects with nosocomial pneumonia (NP) at the test-of-cure (TOC) visit.
    E.2.2Secondary objectives of the trial
    - To compare the microbiological eradication rate following treatment with ceftobiprole plus placebo with linezolid plus ceftazidime in subjects with NP at the TOC visit.
    - To compare the clinical cure rate and microbiological eradication rate following treatment with ceftobiprole plus placebo with linezolid plus ceftazidime in subjects with NP at the late follow-up (LFU) visit.
    - To compare the 30-day pneumonia-specific mortality rates following treatment with ceftobiprole plus placebo with linezolid plus ceftazidime in subject with NP.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1) Written informed consent provided. Consent may be given for unconscious/ incapacitated subjects by their next of kin, guardian or legal representative according to local regulatory and ethical practice using a patient information sheet and informed consent form approved by the responsible Ethics Committee.
    2) Male or female patients aged ≥ 18 years.
    3) Femal subjects must be postmenopausal (for at least 1 year), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of of pregnancy), or practicing an effective method of birth control (e.g. prescription oral contraceptives, contraceptive injections or patch, intrauterine device, double-barrier method (e.g. condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), male partner sterilization or, at the discretion of the investigator, abstinence), before entry and throughout the study; and have a negative serum or urine pregnancy test (depending on local regulations) at screning.
    4) Subject suffering from NP or VAP defined as follows:
    Nosocomial Pneumonia (subject must have a, b, c and d)
    a) Clinical diagnosis of pneumonia after a minimum of 72 hours of hospitalization or in a chronic care facility
    Excemptions would include:
    - ≥48 to <72 hours of hospitalization or in a chronic care facility if at admission no acute inflammatory pulmonary infiltrate was present, WBC and differential blood count was normal, and the reason for admission was not an infection, OR
    - discharge from hospital or chronic care facility ≤48 hours after a stay of ≥72 hours
    b) Clinical signs or 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.
    - Tachypnea (respiratory rate ≥20/minute), particularly if progressive in nature.
    - Hypoxemia with a P02≤60 mmHg while subject is breathing on room air, as determined by pulse oximetry or arterial blood gas, or alveoloar arterial O2 gradient, or respiratory failure requiring mechanical ventilation.
    c) New or persistent (persistance is defined as the infiltrate being radiographically visible for at least 72 Hours) radiographic infiltrates (not related to another disease process)
    d) Fever or leukocytosis/leukopenia consistent with a diagnosis of pneumonia with AT LEAST 1 of the follosing:
    - Fever ((in the absence of anti-pyretics), increase in core temperature of >1°C OR an oral temperature >38°C, a tympanic temperature >38.5°C, a rectal/core temperature >39°C, OR hypothermia, defined as a rectal/core body temperature of <35°C)
    - Leukocytosis (a total WBC count ≥10 x 10exp9/L or ≥15% immature neutrophils (bands), regardless of total peripheral white count; or leucopenia with total WBC ≤4.5 x 10exp9/L )
    Ventilator- Associated Pneumonia
    Subjects with NP (as defined above) who developed pneumonia more than 48 hours after onset of mechanical ventilation.
    5) Microbiological samples (respiratory secretions) suitable for culture and microscopy.
    6) APACHE II score ≥ 8 and ≤ 25.
    E.4Principal exclusion criteria
    1) Female patients who are pregnant or lactating.
    2) Known or suspected hypersensitivity to any related antiinfective (including beta-lactam antibiotics such as penicillins, cephalosporins, oxazolidinone, or monobactams)
    3) Any known or suspected condition or concurrent treatment that would be contraindicated by the prescribing information for linezolid (any medicinal product which inhibits monoamine oxidases A or B, [e.g., phenelzine, isocarboxazid, selegiline, moclobemide] or within 2 weeks of taking any such medicinal product) or ceftazidime. Exception: Subjects with underlying conditions and/or on concomitant medications that might put them at risk from MAO inhibition can only be enrolled if they are hospitalized.
    4) Known or suspected severe renal impairment, (calculated creatinine clearance [CrCl] < 30 mL/minute, or oliguria < 20 mL/h unresponsive to fluid challenge) or any form of dialysis.
    5) Known or suspected hepatic dysfunction (total bilirubin, or alanine aminotransferase [ALT], or aspartate aminotransferase [AST] ≥ 3 x upper limit of the normal range [ULN]).
    6) QTcB (Bazett's correction) > 450 msac at baseline.
    7) Previous enrollment in this study.
    8) Treatment with any investigational drug within 30 days before enrollment.
    9) Any other known or suspected condition of the patient that may jeopardize adherence to protocol requirements (e.g.severe chronic obstructive pulmonary disease [COPD], NYHA Class 4 cardiac disease, burn subjects with >15% total body burn or any significant third degree burn).
    10) Known to be HIV-positive with CD4 counts of ≤0.2x10exp9/L (≤200 cells/mm³). Subjects with HIV and >0.2x10exp9/L [>200 cells/mm³] may be included).
    11) Presence of myelosuppression or neutropenia (absolute neutrophil count [ANC] ≤0.5x10exp9/L [<500 PMNs/mm³]), severe anemia (hemoglobin <6.5 g/dL), or severe thrombocytopenia (<49.9x10exp9/cm). Note; subjects receiving immunosuppressive therapy who are expected to reach a nadir of <500PMNs/mm³ during administration of study drug should not be enrolled.
    12) Children or other family members of the investigator or of emplyees of the study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center.

    Clinical conditions that may interfere with assessment of efficacy:
    13) Sustained shock (e.g., systolic BP < 90 mmHg for > 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents).
    14) Subjects with either- known bronchial obstruction or a history of post-obstructive pneumonia (mild and moderate chronic obstructive pulmonary disease [COPD] patients are allowed) including primary lung cancer or another malignancy metastatic to the lungs, - cystic fibrosis, - lung abscess, - pleural effusion as a primary source of infection- active tuberculosis, or - subjects requiring antibiotic cover for aspiration pneumonia, atypical pneumonia (including Legionella pneumophila) or Pneumocystis jiroveci (carinii) pneumonia.

    Microbiological conditions that may interfere with assessment of efficacy:
    15) Systemic antimicrobial therapy for > 24 hours in the 48 hours prior to enrollment. Exceptions; Systemic antimicrobial therapy for more than 24 hours in the 48 hours prior to enrollment is permitted in case of any of the following: a) the infection is caused by microbiologically-confirmed pathogens that are resistant to the previous antimicrobial agents. b) the patient is clinically deteriorating despite at least 48 hours of antibiotic therapy and is documented to be infected or colonized with a pathogen that is suspectible to both ceftobiprole and the comparator regimen. Note: Subjects with antibiotic use for more than 24 hours in the last 48 hours before enrollment require a confirmed microbiological diagnosis of NP.
    16) Evidence from available surveillance cultures of (co-)infection with pathogen(s) such as: - Extended Spectrum Beta-lactamase producers, - Proteus vulgaris, or - Ceftazidime- or ceftobiprole-resistant nonfermenters
    E.5 End points
    E.5.1Primary end point(s)
    Clinical cure rate, defined as the ratio of the number of clinically cured subjects to the total number of subjects in the population at TOC visit.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 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 No
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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 Information not present in EudraCT
    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 2005-11-22. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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
    unconscious patients with nosocomial pneumonia and ventilation associated pneumonia.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 770
    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 Decision2006-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-05-29
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