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    The EU Clinical Trials Register currently displays   39242   clinical trials with a EudraCT protocol, of which   6428   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-001200-12
    Sponsor's Protocol Code Number:A5951002
    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:2005-02-17
    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 number2004-001200-12
    A.3Full title of the trial
    LINEZOLID IN THE TREATMENT OF SUBJECTS WITH COMPLICATED SKIN AND SOFT TISSUE INFECTIONS 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 numberA5951002
    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 Limited
    B.1.3.4CountryUnited Kingdom
    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 Linezolid
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia
    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 nameLinezolid
    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
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLinezolid
    D.3.9.3Other descriptive name(S)-N-[[3-[3-Flu-oro-4-(4-morphonlinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10049582
    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 complicated skin and soft tissue infections (cSSTI) due to MRSA in adult subjects at the End of Study (EOS) visit.
    E.2.2Secondary objectives of the trial
    To compare the clinical efficacy, and safety and tolerability of linezolid to vancomycin in the treatment of cSSTI due to MRSA in adult subjects at the End of Treatment (EOT) visit.

    To compare the bacteriological efficacy, and safety and tolerability of linezolid to vancomycin in the treatment of cSSTI due to MRSA in adult subjects at the EOT and the EOS visits.

    To compare the medical resource utilization of linezolid and vancomycin for this subject population.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male and female subjects with signs or symptoms consistent with infection, and if available, laboratory findings consistent with staphylococcal infection (e.g., Gram stain and culture results). It is not a requirement to have the results of a Gram stain or culture prior to subject enrollment.

    2. Subject or his/her legally acceptable representative must give informed consent by signing and dating an informed consent form prior to study entry.

    3. Subjects must be at least 18 years of age.

    4. Women of childbearing potential must use adequate contraception, defined as hormonal contraception, intrauterine device, or barrier methods (condom or vaginal diaphragm) with spermicide, throughout the study. The pre-study pregnancy test (urine or serum gonadotropin) must be negative. Women who have been surgically sterilized or are at least two years postmenopausal may be enrolled and do not have to use birth control. Women whose method of birth control is hormonal are required to use an additional barrier method during the study.

    5. Subjects must be in a hospital environment at the time of first study dose. Non-hospitalized subjects may be enrolled as long as the first dose of study drug is given in a hospital environment. A hospital environment can include an emergency room, long term care facility such as a nursing home or rehabilitation center, or a wound center/infusion center/ambulatory treatment center that is at or attached to the hospital site.

    6. Subjects must be expected to survive with effective antibiotic therapy and appropriate supportive care throughout the period of treatment and follow-up.

    7. Subjects must be willing to complete all study related activities.

    8. Subjects who, after control of their acute infection, are likely to be eligible to be discharged to outpatient therapy. In addition, the following subjects who may require long term hospitalization can be enrolled:

    · Trauma and orthopedic patients with infections not involving bone (or if involving bone as per exclusion #8)
    · Subjects who are expected to require surgical treatment after the study infection has resolved during the same hospitalization (i.e., skin graft for burn or ulcer)
    · Subjects who are randomized to the vancomycin treatment group and the study site's local health practice requires that they stay in the hospital until the end of the treatment period

    9. Subjects must have at least two of the specific signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA that involves deep tissues such as subcutaneous tissue, fascia or skeletal muscle. Signs or symptoms may include:
    · purulent drainage
    · erythema
    · swelling/induration
    · tenderness to palpation or pain
    · local warmth

    E.4Principal exclusion criteria
    1. Subjects who have received an 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 any other protocol using linezolid in the past 6 months. Subjects who have previously participated in this trial are also excluded.

    2. Subjects of childbearing potential, who are unable to take adequate contraceptive precautions, have a positive pregnancy test result within 24 hours prior to study entry, are otherwise known to be pregnant, or are currently breastfeeding an infant.

    3. Subjects with infected devices, where the device is not removed. Subjects with the following infected devices – intravascular catheters/devices, CNS shunts, or peritoneal dialysis (PD) catheters, even if the device is removed, should be excluded.

    4. Subjects with a hypersensitivity to vancomycin, teicoplanin, oxazolidinones or any of the excipients in the IV or oral formulation of linezolid.

    5. Subjects with MRSA known to be non-susceptible to either of the study drugs before study entry.

    6. Subjects who were treated with a previous antibiotic (systemic or topical) with activity against a subject's MRSA isolate (other than linezolid, vancomycin or teicoplanin) with a duration of more than 24 hours unless documented to be a treatment failure (defined as 72 hours of treatment and not responding). Treatment duration is defined as the time during which doses are administered plus time from last dose administered to next scheduled dose. The combined duration of antibiotics with activity against MRSA should not exceed 24 hours if given consecutively in the preceding 72 hours prior to first dose of study drug The treatment duration applies to any of the following timeframes:
    · Within the 72-hour pre-enrollment period
    · Started prior to the 72-hour pre-enrollment period and extended into this period
    · Started during the 72-hour pre-enrollment period and extended into the study drug treatment period

    Exception: Subjects who had greater than 24 hours of an antibiotic (other than linezolid, vancomycin or teicoplanin) that can have activity against MRSA, can be enrolled if they can show the following:
    · MRSA isolate is non-susceptible to the antibiotic, or
    · Institution's pattern of susceptibility indicates that the MRSA isolate is likely to not be susceptible to the antibiotic
    · The subject has been treated for > 72 hours and was a documented treatment failure

    Certain drugs with variable MRSA activity (e.g. fluoroquinolones, clindamycin, trimethoprim-sulfamethoxazole and tetracycline) may not be excluded if local susceptibility patterns will predict resistance and resistance is subsequently documented (Refer to Section 5.4.1).

    7. Subjects who were treated with linezolid, vancomycin or teicoplanin with a treatment duration of more than 24 hours. The treatment duration applies to any of the following timeframes:
    · Within the 72-hour pre-enrollment period
    · Started prior to the 72-hour pre-enrollment period and extended into this period
    · Started during the 72-hour pre-enrollment period and extended into the study drug treatment period

    Subjects who were treated previously with linezolid, vancomycin or teicoplanin for the infection under study are excluded if they received a treatment duration of 72 hours or more of treatment and did not respond

    8. Subjects with known or suspected necrotizing fasciitis, gas gangrene, gangrene, septic arthritis or osteomyelitis. Subjects may be enrolled if the area of osteomyelitis or gangrene has been or will be (within 72 hours of enrollment) resected (e.g. amputated) and an area of complicated skin/soft tissue infection requiring systemic antibiotic treatment remains. (If gangrene, evidence of critical ischemia must be ruled out as per Exclusion Criteria #9.)

    9. Subjects with an infection involving a limb with evidence of critical ischemia in the affected limb defined as any of the following criteria:
    · Absent or abnormal Doppler wave forms
    · Toe blood pressure of <45 mm Hg
    · Ankle brachial index of <0.5
    · Critical ischemia as assessed by a vascular surgeon

    10. Subjects with rapidly fatal underlying disease not expected to survive to complete the study.

    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the clinical outcome at the EOS visit, in subjects with baseline MRSA.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    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
    Tolerability
    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) Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Vancomycin as comparator with Aztreonam(IV) infusion 1-2 grams every 12 hours as required for suspec
    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
    End of Trial in a Member State of the European Union is defined as the time at which it is deemed that sufficient subjects have been recruited and completed the trial as stated in the regulatory application.

    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 months
    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 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) Information not present in EudraCT
    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 2005-02-17. 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 No
    F.3.3.7Others Information not present in EudraCT
    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 260
    F.4.2.2In the whole clinical trial 1000
    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)
    After the subject has ended treatment they will continue their standard of care. Subjects will be on up to 14days of drug as per study unless they have documented bacteremia in which case they will be on 21 days of drug.
    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 Decision2004-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-11-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-07-23
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