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    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   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:2004-000827-13
    Sponsor's Protocol Code Number:A5951001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-11-30
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-000827-13
    A.3Full title of the trial
    Linezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA5951001
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorPfizer, S.A.
    B.1.3.4CountrySpain
    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.2.1.1.1Trade name Zyvox / Linezolid
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia & Upjohn, UK.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameZyvox / Zyvoxid / Linezolid
    D.3.2Product code PNU-100766
    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.3.9.3Other descriptive nameOxazolidinone antibiotic
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typenot less then
    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: 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 Vancomycin Abbott 1000 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott GmbH & Co. KG, Max-Planck-Ring 2, 65205 Wiesbaden, Germany.
    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.3.1Product nameVancomycin Abbott 1000 mg
    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 INNVancomycin
    D.3.9.3Other descriptive nameVancomycin hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number30 /day
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    MRSA Infection - Nosocomial Pneumonia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    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 compare the clinical efficacy of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults.
    E.2.2Secondary objectives of the trial
    To compare the bacteriological efficacy and the safety and tolerability of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Male and female subjects with a diagnosis of nosocomial pneumonia meeting all criteria listed below will be included in the study.

    1. Hospitalized males and females aged 18 years of age and over.
    2. Subject must have clinically documented pneumonia (acquired ≥ 48 hours after hospitalization in an in-patient health care facility or chronic care facility) with at least two of the following signs and symptoms:
    • cough
    • new onset of purulent sputum production or a change (worsening) in character of the sputum
    • auscultatory findings on pulmonary exam of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony)
    • dyspnea, tachypnea, or hypoxemia with a PO2 < 60 mmHg, particularly if any or all of these are progressive in nature
    • organism consistent with S. aureus or MRSA isolated from respiratory, sputum, or blood cultures
    3. Subject must also have at least two of the following:
    • Fever within 6 hours prior to study entry, defined as body temperature ≥38°C (100.4°F) taken orally, ≥38.5°C (101.2°F) tympanically, or ≥39°C (102.2°F) rectally or hypothermia defined as body temperature ≤35.5°C (96°F) taken orally
    • respiratory rate > 30 breaths per minute
    • systolic hypotension (systolic blood pressure < 90 mm Hg)
    • pulse rate ≥ 120 beats per minute
    • temporarily altered mental status consistent with sepsis
    • Elevated total peripheral white blood cell count (WBC) >10,000/mm3
    • >15% immature neutrophils (bands) regardless of total peripheral WBC
    • leukopenia with total WBC <4,500/mm3
    4. Subject must have a positive chest X-ray (PA or AP with lateral if possible) at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia (new or progressive infiltrates, consolidation, or pleural effusion). CT scan of the thorax may be used to confirm diagnosis of pneumonia.
    5. Subject must have a culture taken by an invasive technique within 24 hours of study entry or have a suitable sputum/tracheal specimen defined as having less than or equal to 10 squamous epithelial cells and greater than or equal to 25 leukocytes per low power field (10 x objective).
    6. Subject must have venous access available for intravenous dosing.
    7. Subject or his/her legally acceptable representative must give informed consent by signing and dating an informed consent form prior to study entry.
    8. Subject must be willing to complete all study-related activities and follow-up visits.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:

    1. Subject of childbearing potential, who is unable to take adequate contraceptive precautions, has a positive pregnancy test result within 24 hours prior to study entry, is otherwise known to be pregnant, or is currently breastfeeding an infant.
    2. Subject with an infection due to organisms known to be resistant to either of the study drug regimens before study entry.
    3. Subject with known or suspected pulmonary conditions which are likely to preclude evaluation of therapeutic response, e.g., granulomatous diseases, lung cancer, or another malignancy metastatic to the lungs.
    4. Subject with known bronchial obstruction or a history of post-obstructive pneumonia.
    5. Subject with rapidly fatal underlying disease not expected to survive to complete the study.
    6. Subject with empyema as confirmed by thoracentesis or lung abcess if visible on plain radiograph.
    7. Subject who has a recent history of bone marrow transplant or lung transplant.
    8. Subject who has cystic fibrosis or with known or suspected active tuberculosis.
    9. Subject with pheochromocytoma, untreated hyperthyroidism, untreated or uncontrolled hypertension, or carcinoid syndrome.
    10. Subject with known or suspected meningitis, endocarditis, or osteomyelitis.
    11. Subject who has clinical aids with a CD4 cell count < 200 cells/mm3 secondary to HIV infection.
    12. Subject 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.
    13. Subject with a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.
    14. Subject who was treated with a previous antibiotic for more than 48 hours, unless documented to be a treatment failure (72 hours of treatment and not responding) or if the isolated pathogen for the current pneumonia is resistant in vitro to previous non-study antibiotic therapy.
    15. Subject who has received any investigational drug during the previous 30 days or five times the plasma half-life (if known), whichever is longer or who have previously participated in this trial or any other protocol using linezolid.
    16. Subject with a hypersensitivity to oxazolidinones or one of the excipients in the IV formulation of linezolid.
    17. Subject with a hypersensitivity to vancomycin.
    18. Subject who has known liver disease and SGPT and/or SGOT > 5 X ULN (upper limit of normal).
    19. Subject who has severe neutropenia (< 500 cells/mm3)
    20. Subject who is a recent abuser of alcohol and/or other drugs that would result in his/her inability to participate in this trial.
    21. Subject in whom concurrent use of certain medications with study drug may interfere with the evaluation of the study drug.
    22. Subject who intends to donate blood or blood products during the study or within one month following the completion of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical response will be determined by the investigator and evaluated at EOT and EOS for subjects with baseline MRSA pathogen. Clinical response will be based primarily on the global assessment of the clinical presentation of the subject made by the investigator at the evaluation timepoint. Bacteriological response will be determined by the Sponsor and evaluated at the EOT and at the EOS visits for subjects with a baseline MRSA pathogen. Ninety-five percent confidence intervals will be used to assess treatment effect.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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.8.6 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
    Subjects who do not have confirmed MRSA or an organism resistant to any of the study treatments should be discontinued. Any subject may be discontinued from the study at any time if it is in their best interest. This study may be terminated or suspended at any time and the Sponsor will inform the investigators, the IECs and the regulatory authorities and provide the reason(s) for the termination or suspension, as specified by the applicable regulatory requirement(s).
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 2005-11-30. 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
    In this study some patients may be unable to give consent as a result of their medical condition , in such cases a legally authorised representative must give assent for the patient.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 1200
    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)
    The study treatments are both licensed for the short term treatment for bacterial infection. If treatment fails the investigator will use an appropriate other treatment.
    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 Decision2005-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-30
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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