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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2005-001349-40
    Sponsor's Protocol Code Number:DAP002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-06-01
    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 number2005-001349-40
    A.3Full title of the trial
    A Multicentre, Randomised, Assessor-Blind Study to Evaluate Efficacy and Safety of Daptomycin versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections (cSSTI)
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberDAP002
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    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 SponsorNovartis Pharma Services AG
    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 Yes
    D.2.1.1.1Trade name Cubicin, 350 mg powder for concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd
    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 nameDaptomycin
    D.3.2Product code CB-109187
    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 INNDaptomycin
    D.3.9.1CAS number 103060-53-3
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 No
    D.3.11.8Extractive medicinal product Yes
    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 Yes
    D.2.1.1.1Trade name Targocid 400 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma Limited
    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 nameTeicoplanin
    D.3.4Pharmaceutical form Powder for injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTeicoplanin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 No
    D.3.11.8Extractive medicinal product Yes
    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 Yes
    D.2.1.1.1Trade name Vancomycin hydrochloride 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMayne Pharma Plc
    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 nameVancomycin hydrochloride
    D.3.4Pharmaceutical form Powder for injection*
    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 hydrochoride
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 No
    D.3.11.8Extractive medicinal product Yes
    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
    Complicated Skin and Soft Tissue Infections (cSSTI)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level HLT
    E.1.2Classification code 10040786
    E.1.2Term Skin structures and soft tissue infections
    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 daptomycin to that of the comparator arm (vancomycin or teicoplanin) in the treatment of cSSTI as measured by the proportion of subjects achieving clinical success at the Test-of-Cure (TOC) visit (Day +7 to Day+14)
    E.2.2Secondary objectives of the trial
    To compare the time to resolution of clinical signs and symptoms of cSSTI in the daptomycin arm with that of the comparator arm, according to a SSTI signs & symptoms scoring system.

    To compare the time to resolution of fever in daptomycin-treated subjects with that in comparator-treated subjects.

    To compare the microbiological efficacy of daptomycin with that of vancomycin or teicoplanin in the treatment of cSSTI as measured by the proportion of subjects achieving bacteriological eradication of Gram-positive baseline pathogens at the TOC visit.

    To assess and compare the resource utilisation, treatment cost, and cost-effectiveness of daptomycin with the comparator treatment over the treatment and follow-up period.

    To compare the duration of treatment with daptomycin with that of comparator.

    To compare safety of treatment with daptomycin with that of comparator.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects with a diagnosis of cSSTI defined as infection normally requiring surgical/local debridement of sufficient severity to warrant hospitalisation and i.v. antimicrobial treatment.

    2. Infection known or suspected (based on Gram's stain) to be due, at least partially, to Gram-positive bacteria.

    3. Hospitalised subjects with clinical evidence of at least one of the following:
    - Infected ulcers includig diabetic foot ulcers not associated with osteomyelitis
    - Major abscess
    - Deep or extensive cellulitis
    - Post-surgical/post traumatic wound infection

    4. Presence of at least two of the following signs and symptoms:
    - Drainage and/or discharge from the infection site
    - Erythema
    - Edema and/or induration
    - Heat and/or localised warmth
    - Pain and/or tenderness to palpation
    - Fluctuance

    5. Presence of at least one of the following
    - Temperature >38.0 degrees C rectal or >37.5 degrees oral/tympanic
    - WBC >12 x 1000/L or with >10% bands

    6. Written informed consent to participate in the study.

    7. Males and females at least 18 years of age.

    8. Women of childbearing potential must have a negative serum or urine pregnancy test at Baseline and must agree to an effective method of contraception throughout the study period.
    E.4Principal exclusion criteria
    1. cSSTIs of the following categories:

    - Infected burns
    - Severely impaired arterial blood supply such that the likelihood of amputation of the infected anatomical site is likely
    - Decubitus ulcers
    - Infected diabetic foot ulcers associated with osteomyelitis
    - Infected human or animal bites
    - Superficial infections or abscesses in an anatomic site, such as the rectal area, where the risk of anaerobic or Gram-negative pathogen involvement is high (e.g. perirectal abscess)
    - Necrotising fasciitis or gangrene
    - cSSTI expected to require more than 14 days of intravenous antimicrobial therapy
    - Skin and/or skin structure infection that can be treated by surgery alone
    - Infections associated with a permanent prosthetic device that will not be removed within 2 days of study randomisation

    2. Uncomplicated skin or soft tissue infection (e.g., simple abscesses, folliculitis, impetiginous lesions, furunculosis, superficial cellulitis).
    3. Subjects with documented bacteraemia at Baseline.
    4. Shock or hypotension (supine systolic blood pressure <80 mmHg) refractory to fluid or short course pressor challenge (four hours or less).
    5. Concomitant clinically suspected or confirmed other site of infection or disorder at study entry that may interfere with the evaluations in this protocol (e.g. primary muscle disorders, endocarditisetc).
    6. Treatment with vancomycin or teicoplanin within the past 48 hours, unless administered for less than 24 hours.
    7. Subjects admitted to the hospital for conditions associated with rhabdomyolysis.
    8. Subjects with an infection due to an organism known prior to study entry to be resistant to daptomycin, vancomycin or teicoplanin.
    9. Previously diagnosed disease of immune function (e.g. AIDS, neutrophil count <1000mm/m3).
    10. Subjects receiving oral steroids >10 mg per day prednisolone or equivalent or receiving immunosuppressant drugs after organ transplant.
    11. Subjects who have received more than 48 hours of any systemic antibiotic or topical antibiotic at the infection site against Gram-positive pathogens within 48 hours of enrolment, unless these is clinical evidence of treatment failure OR documented resistance in the identified Gram-positive pathogen to the previous antibiotic therapy.
    12. Complicated SSTI that is known or suspected to be a fungal, parasitic or viral infection.
    13. Subjects diagnosed with pneumonia.
    14. Pregnant or lactating women.
    15. Severe renal impairment with creatinine clearance (CrCl) <30 mL/min or dialysis.
    16. Severe hepatic disease (Child-Pugh Class C) or known ALT and/or AST >3 times the upper limit of normal and/or bilirubin >1.5 times the upper limit of normal.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable related to the primary objective of the study is the Clinical Success (i.e. clinical cure or clinical improvement) at the Test-of-Cure (TOC) visit in the Clinically Evaluable (CE) study population.

    At the time of the TOC assessment, clinical response will be determined in the CE population by comparing the subject's signs and symptoms to those recorded at the Study Baseline and classified into the following categories as described in the protocol:
    - Success
    - Failure
    - Unable to evaluate
    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 Yes
    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 Yes
    E.8.1.4Double blind No
    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.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 visit of 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 months6
    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 months6
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 280
    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 Decision2005-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-31
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-05-06
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