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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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:2004-002798-21
    Sponsor's Protocol Code Number:WI18273
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-12-23
    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 ConcernedLatvia - SAM
    A.2EudraCT number2004-002798-21
    A.3Full title of the trial
    A Phase II, prospective, randomized, double-blind, active-controlled, parallel group, multi-center 'proof of concept' trial in adult patients with community-acquired pneumonia requiring hospitalization without evidence of Legionella
    A.3.2Name or abbreviated title of the trial where available
    CAPTURE
    A.4.1Sponsor's protocol code numberWI18273
    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 SponsorF.Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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.3.2Product code RO 490 8463
    D.3.4Pharmaceutical form Intravenous 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.3.9.2Current sponsor codeRO 490 8463
    D.3.9.3Other descriptive nameCS 023
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number750
    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 Information not present in EudraCT
    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 Rocephin
    D.2.1.1.2Name of the Marketing Authorisation holderHoffmann-La Roche Ltd pārstāvniecība Latvijā
    D.2.1.2Country which granted the Marketing AuthorisationLatvia
    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 nameceftriaxone
    D.3.4Pharmaceutical form Intravenous 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 INNCeftriaxone
    D.3.9.1CAS number 104376-79-6
    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 Information not present in EudraCT
    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
    Community-acquired pneumonia
    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
    To compare the safety, tolerance and efficacy of parenteral RO4908463 to ceftriaxone in patients with community-acquired pneumonia requiring hospitalization without evidence of Legionella.
    E.2.2Secondary objectives of the trial
    To obtain in vitro susceptibility data on RO4908463 on the pathogenic organisms isolated from patients participating in the study.

    To evaluate the pharmacokinetics of RO4908463 in the patient population including the influence of covariates.

    To explore the relationship of drug exposure (time above minimum inhibitory
    concentration (MIC)) to clinical cure rates in the bacteriologic evaluable population.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients will qualify to participate in this study if they meet all of the following:
    1. Are male or female patients greater than or equal to 18 years of age that require hospitalization with community-acquired pneumonia or develops pneumonia within 48 hours of hospitalization for another condition.
    2. Have fever defined as body temperature > 38.0°C (100.4°F) taken orally; or > 38.5°C (101.2°F) tympanically; OR have hypothermia, defined as rectal or core body
    temperature < 36°C (96.8°F).
    3. Have a new or increased cough productive of purulent sputum for culture and
    susceptibility testing.
    4. Have either pleuritic chest pain, dyspnea, or tachypnea.
    5. Have auscultatory findings consistent with pneumonic consolidation or pneumopathic process consistent with the diagnosis of pneumonia.
    6. Have chest x-ray confirmation of infiltrate or lobar consolidation.
    7. Have obtained respiratory secretion specimen and two blood cultures. (Respiratory
    secretions may be obtained by any of the following means: deep expectoration either unassisted or in conjunction with hydration followed by chest physiotherapy and nebulization treatments, nasotracheal aspiration, bronchoscopy with endobronchial lavage or protected-brush sampling, transtracheal aspiration, percutaneous lung or pleural fluid aspiration).
    8. Have a negative urine Legionella antigen test (Binax®).
    9. Have APACHE II score greater than or equal to 9 and less than or equal to 24.
    10. If the patient is sexually active and is female of child bearing potential, or is a sexually active male who has a female partner of child bearing potential, then the patient agrees to use two forms of contraception, at least one of which is a barrier method, during the study period.
    11. Have an elevated total peripheral white blood cell count (WBC) greater than or equal to 10,000/mm3, or 15 % immature neutrophils (bands), regardless of total peripheral white count, or leukopenia with total WBC < 4500/mm3.
    12. Have signed an informed consent.
    E.4Principal exclusion criteria
    Patients will be excluded if they meet any of the following:
    1. Have a Pneumonia Severity Index ≤ 90.
    2. Have presented with sustained shock, defined as systolic blood pressure < 90 mm Hg for > 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure.
    3. In the opinion of the investigator, history, physical examination and chest X-ray
    findings are most consistent with an atypical pneumonia.
    4. Require endotracheal intubation and ventilation, or in the opinion of the investigator, are expected to require it.
    5. Are likely to be discharged in less than 3 days.
    6. Developed pneumonia after more than 48 hours of admission to hospital.
    7. Have been a resident in a nursing home or extended care facility within 60 days prior to randomization.
    8. Require hemodialysis, peritoneal dialysis, plasmapheresis or hemoperfusion.
    9. Have a known bronchial obstruction or a history of post-obstructive pneumonia.
    10. Have known or suspected lung abscess, empyema, or evidence of a pleural effusion estimated to be > 500 mL.
    11. Have primary lung cancer or another malignancy metastatic to the lungs.
    12. Have signs of meningitis such as nuchal rigidity, papilledema or other findings of
    meningitis. (Note: The penetration of RO4908463 into the cerebral spinal fluid (CSF) has not yet been determined.)
    13. Have known or suspected cystic fibrosis or suspected active tuberculosis.
    14. Have known or suspected concomitant bacterial infection requiring antibiotic
    treatment.
    15. Require chronic immunosuppressive therapy or have an anticipated need for
    immunosuppressive therapy for > 1 month from baseline (including > 10 mg/day of
    systemic prednisone or equivalent).
    16. Have neutropenia (ANC < 1000/mm3) or platelet count < 50,000/mm3.
    17. Have any form of epilepsy or history of seizures.
    18. Have been alcohol or drug dependent within the past six months.
    19. Have hypersensitivity to beta-lactam antibiotics.
    20. Have had more than one dose of a short acting, 3rd generation cephalosporin (e.g., cefotaxime) or any dose of a quinolone, macrolide or ketolide within 24 hours of
    being randomized for participation in the study.
    21. Have a history of cerebrovascular accident, transient ischemic attack(s), brain
    metastases, space occupying lesion in the CNS or systemic malignancy within past
    year and/or are currently receiving adjuvant chemotherapy.
    22. Are receiving or likely to receive coumarin or probenecid therapy during the study.
    23. Have a creatinine clearance, using the Cockcroft-Gault equation, of ≤ 70 mL/min.
    24. Have significant proteinuria (e.g. 4+ or > 1.0% or > 10g/L on urinalysis).
    25. Have evidence of a liver dysfunction manifested by: ALT or AST ≥ 4X ULN or total
    bilirubin > 1.5X ULN.
    26. Have a history of hemolytic anemia.
    27. Have artificial heart valves or vascular prostheses.
    28. Have known HIV infection or AIDS with a CD4 count < 250 cells/mm3 and are
    taking antiretroviral therapy or in the opinion of the investigator should begin
    antiretroviral treatments or have undiagnosed HIV infection but have clinical findings
    highly suggestive of HIV/AIDS.
    29. Are unlikely to comply with the dosing regimen, scheduled assessments, or complete the study for any other reason.
    30. Have previously been randomized into this study or are ancillary personnel involved with this study.
    31. Are pregnant or nursing.
    32. Have any concomitant condition which could preclude evaluation of response or
    make it unlikely that a course of therapy and follow-up evaluations could be
    completed.
    33. Have received an investigational medication within 30 days of entry into the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the clinical cure rate at the end of study evaluation 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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 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 No
    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 years1
    E.8.9.1In the Member State concerned months3
    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 months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Information not present in EudraCT
    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 Information not present in EudraCT
    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 2004-12-23. 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients will be acutely ill, with a life threatening illness. The protocol allows investigators to obtain consent from a legally acceptable representative, where subjects are not qualified or incapable of giving consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 300
    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 Decision2004-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-02-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-07-10
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