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    Summary
    EudraCT Number:2015-004886-98
    Sponsor's Protocol Code Number:TOC110978
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-01-24
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-004886-98
    A.3Full title of the trial
    A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, versus Oral Linezolid in the Treatment of Secondarily-Infected Traumatic Lesions and Impetigo Due to Methicillin-Resistant Staphylococcus aureus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of Safety and Efficacy between Retapamulin Ointment, 1% and Oral Linezolid in the treatment of Secondarily-Infected Traumatic Lesions and Impetigo.
    A.4.1Sponsor's protocol code numberTOC110978
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline
    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 supportGlaxoSmithKline
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research and Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 0208 990 44 66
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    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 No
    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 nameRetapamulin
    D.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRETAPAMULIN
    D.3.9.1CAS number 224452-66-8
    D.3.9.4EV Substance CodeSUB25391
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 No
    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 Linezolid
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLINEZOLID
    D.3.9.3Other descriptive nameLINEZOLID
    D.3.9.4EV Substance CodeSUB08520MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 No
    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 Linezolid
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLINEZOLID
    D.3.9.3Other descriptive nameLINEZOLID
    D.3.9.4EV Substance CodeSUB08520MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral suspension
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    secondarily-infected traumatic lesions (SITL; excluding abscesses) or impetigo due
    to methicillin-resistant Staphylococcus aureus (MRSA
    E.1.1.1Medical condition in easily understood language
    Infected skin lesions
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10021531
    E.1.2Term Impetigo
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 of this study is to evaluate the clinical and bacteriological efficacy
    of topical retapamulin ointment, 1%, versus oral linezolid, in the treatment of subjects
    with secondarily-infected traumatic lesions (SITL; excluding abscesses) or impetigo due
    to methicillin-resistant Staphylococcus aureus (MRSA).
    E.2.2Secondary objectives of the trial
    To evaluate the safety of topical retapamulin ointment, 1%, versus linezolid, in the
    treatment of subjects with SITL (excluding abscesses) or impetigo due to MRSA.
    To evaluate the efficacy and safety of topical retapamulin ointment, 1%, versus linezolid,
    in the treatment of subjects with SITL (excluding abscesses) or impetigo, without regard
    to pathogen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject is aged 2 months or older.
    2. The subject has a secondarily infected traumatic lesion (SITL) or impetigo (bullous
    or non-bullous).
    3. The subject has had a negative urine pregnancy test prior to enrolment (if of
    childbearing potential).
    4. The subject has a Total Skin Infection Rating Scale (SIRS) Score of at least 8, which
    must include a pus/exudate score of at least 3 (see Appendix 1).
    5. The subject and/or parent/legal guardian is willing and able to comply with the study
    protocol.
    6. The subject or parent/legal guardian, as applicable, has given written informed, dated
    consent; and the subject has given written assent, if applicable, to participate in the
    study.
    E.4Principal exclusion criteria
    1. The subject has demonstrated a previous hypersensitivity reaction to pleuromutilins
    or any component of the retapamulin ointment, or to oxazolidinones.
    2. The subject has phenylketonuria (PKU) or known hypersensitivity to aspartame.
    3. The subject has a secondarily infected animal/human bite, or a puncture wound.
    4. The subject has an abscess; defined as a localized collection of pus caused by
    suppuration buried in tissues.
    5. The subject has a chronic ulcerative lesion that is likely to be polymicrobial and
    unlikely to have Staphylococcus aureus as the causative agent.
    6. The subject has an underlying skin disease, such as pre-existing eczematous
    dermatitis, with clinical evidence of secondary infection.
    7. The subject has systemic signs and symptoms of infection (e.g., a fever; defined as a
    rectal temperature greater than 101° F or 38.3° C).
    8. The subject has a bacterial skin infection which, due to extent, depth or severity, in
    the opinion of the investigator, cannot be appropriately treated by a topical antibiotic
    (e.g., extensive cellulitis, furunculosis).
    9. The subject requires surgical intervention including, but not limited to, incision and
    drainage, for treatment of the infection prior to enrollment in the study, or is likely to
    require such intervention during the course of the study. This includes subjects who
    have infected surgical wounds from an amputation.
    10. The subject has received a systemic antibacterial or steroid, or has applied any
    topical therapeutic agent (including glucocorticoid steroids, antibacterials and
    antifungals) directly to the wound, within 24 hours of entry into the study.
    11. The subject is currently receiving adrenergic agents (e.g., pseudoephedrine).
    12. The subject is currently receiving serotonergic agents (i.e., antidepressants).
    13. The subject has a clinical history of pseudomembranous colitis.
    14. The subject has known, pre-existing myelosuppression, or a history of
    myelosuppression with prior linezolid use, or is currently receiving a medication that
    produces bone marrow suppression.
    15. The subject has a history of seizures.
    16. The subject has a history of severe renal failure and is undergoing dialysis.
    17. The subject has a serious underlying disease that could be imminently lifethreatening.
    18. The subject is pregnant, breast feeding or planning a pregnancy during the study, or
    of childbearing potential or less than one year post-menopausal and not using an
    accepted method of contraception (i.e., surgical sterilization, intra-uterine
    contraceptive device, oral contraception plus barrier contraception, other hormone
    delivery systems plus barrier contraception, diaphragm or condom in combination
    with contraceptive cream, jelly or foam).
    19. The subject has used an investigational drug within 30 days prior to entering the
    study.
    20. The subject has been previously enrolled in this study
    21. The subject has fructose intolerance, glucose-galactose malabsorption, or sucraseisomaltase
    insufficiency.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the clinical response at follow-up (7-9 days post-therapy; Day
    12-14 for retapamulin and Day 17-19 for linezolid) in subjects with MRSA as the
    baseline pathogen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    (7 to 9 days post-therapy; ie. Day 12 to 14 for retapamulin and Day 17 to 19 for linezolid)
    E.5.2Secondary end point(s)
    • Microbiological response at follow-up in subjects with MRSA as the baseline
    pathogen
    • Clinical response at follow-up in all subjects
    • Microbiological response at follow-up in all subjects with a baseline pathogen
    • Clinical outcome at end of therapy (2-4 days post-therapy; Day 7-9 for retapamulin
    and Day 12-14 for linezolid) in subjects with MRSA as the baseline pathogen
    • Microbiological outcome at end of therapy in subjects with MRSA as the baseline
    pathogen
    • Clinical outcome at end of therapy in all subjects
    • Microbiological outcome at end of therapy in all subjects with a baseline pathogen
    • Therapeutic response (combined clinical and microbiological response) at follow-up
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of therapy (2 to 4 days post-therapy; ie. Day 7 to 9 for retapamulin and Day 12 to14 for linezolid) or at follow up (7 to 9 days post-therapy ie. Day 12 to 14 for retapamulin and Day 17 to 19 for linezolid)
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 No
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Last subject last visit – 27-Sep-2010
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days19
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 116
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 14
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 78
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 38
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 256
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Paediatrics
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 500
    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)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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