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    Summary
    EudraCT Number:2015-002778-19
    Sponsor's Protocol Code Number:DAP-PEDS-07-03
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-06-29
    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 number2015-002778-19
    A.3Full title of the trial
    An Evaluation of the Safety, Efficacy and Pharmacokinetics of Daptomycin in Pediatric Subjects Aged One to Seventeen Years With Complicated Skin and Skin Structure Infections Caused by Gram-Positive Pathogens
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections
    A.4.1Sponsor's protocol code numberDAP-PEDS-07-03
    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 SponsorCubist Pharmaceuticals, Inc.
    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 supportCubist Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCubist Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointVice President, Clinical Research
    B.5.3 Address:
    B.5.3.1Street Address65 Hayden Avenue
    B.5.3.2Town/ cityLexington
    B.5.3.3Post codeMA 02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number781860-8660
    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®
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    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.3.9.4EV Substance CodeSUB06910MIG
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Complicated skin and skin structure infections (cSSSI) caused by Gram-positive pathogens
    E.1.1.1Medical condition in easily understood language
    Complicated skin and skin structure infections (cSSSI) caused by Gram-positive pathogens.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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 assess the safety of age dependent doses of intravenous (IV) DAP administered for up to 14 days in comparison with standard of care (SOC) therapy in pediatric subjects aged 1 to 17 years with cSSSI caused by Gram-positive pathogens.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of age-dependent doses of IV DAP administration for up to 14 days in comparison with SOC therapy in pediatric subjects aged 1 to 17 years with cSSSI caused by Gram-positive pathogens.

    To evaluate the population PK of age-dependent doses of IV DAP administered for up to 14 days in pediatric subjects aged 1 to 17 years with cSSSI caused by Gram-positive pathogens.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care
    • Written participant assent (as appropriate)
    • Male or female between the ages of 1 and 17 years old, inclusive
    • If female of childbearing potential (defined as post-menarche), not lactating or pregnant, documented negative pregnancy test result within 48 hours prior to study medication administration and willing to practice reliable birth control measures (at the discretion of the Principal Investigator) during study treatment and for at least 28 days after study completion
    • Able to comply with the protocol for the duration of the study
    • Skin and skin structure infections of a complicated nature known or suspected to be caused by Gram-positive pathogen(s) that require IV antibiotic treatment. Complicated infections are defined as infections either involving deep soft tissue or requiring significant surgical intervention (such as, infected ulcers, burns, and major abscesses) or infections in which the participant has a significant underlying disease state that complicates the response to treatment. The Investigator may contact the Medical Monitor to discuss infections not meeting this definition but which otherwise appear appropriate for inclusion
    • At least three of the following clinical signs and symptoms associated with the cSSSI: pain; tenderness to palpation; temperature >37.5 degrees Celsius (C) (99.5 degrees Fahrenheit [F]) oral or >38 degrees C (100.4 degrees F) rectal; white blood count (WBC) >12,000/cubic millimeter (mm^3) or ≥10% bands; swelling and/or induration; erythema (>1 centimeter [cm] beyond edge of wound or abscess); or pus formation
    E.4Principal exclusion criteria
    • Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry
    • Known allergy/hypersensitivity to daptomycin
    • Known infection caused solely by Gram-negative pathogen(s), fungus(i), or virus(es)
    • Previous systemic antimicrobial therapy exceeding 24 hours in duration administered anytime during the 48 hours prior to the first dose of study drug (exception: a participant is eligible if on previous antibiotics without any clinical improvement and/or a wound culture is available and the pathogen is not sensitive to prior therapy)
    • Known or suspected pneumonia, osteomyelitis, meningitis, or endocarditis
    • Known bacteremia (exception: any participant enrolled in the study that is subsequently found to have a blood culture positive for bacteremia may be continued)
    • Participant with current or known clinically significant abnormal laboratory test results (including electrocardiograms [ECGs]) that would expose the participant to unacceptable risk as determined by Investigator
    • History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematological, autoimmune disease, or primary immune deficiency (unless the Investigator considers that the subject would not be at risk by participating in the study [Note: human immunodeficiency virus-infected participants must not be enrolled])
    • History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system, or seizure disorder
    • Unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barre syndrome or spinal cord injury
    • Known or suspected renal insufficiency (that is, estimated creatinine clearance rate [CLcr]<80 mL/min/1.73 squared meter [m^2]
    • History of or current rhabdomyolysis
    • History of (within 1 year prior to first dose of study drug) or current myositis
    • Current septic shock
    • Known or suspected creatine phosphokinase (CPK) elevation
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of Safety: The safety of daptomycin and SOC will be evaluated by monitoring adverse events (AEs), serious
    adverse events (SAEs), serum chemistry (including serum CPK level) and changes in physical and focused neurological and
    other laboratory examinations.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety will be assessed from the administration of the first dose of study medication through the last follow-up visit (7-14 days after last dose of study medication). Focused neurological examinations will be done at baseline, at End-of-Therapy (EOT) and Test-of-Cure (TOC: 7-14 days after last dose of study medication). Samples for routine laboratory testing will be collected at Screening/Baseline, weekly while the subject was on therapy, at the EOT and TOC/Safety visits.
    E.5.2Secondary end point(s)
    1).Evaluation of Post-therapy clinical response was determined by comparing the subject’s signs and symptoms at the EOT and TOC Visits to those recorded at Study Baseline as follows:
    • Cure: Resolution of clinically significant signs and symptoms associated with the skin
    infection present at Study Baseline.
    • Improved: Partial resolution of clinical signs and symptoms of the skin infection.
    • Failure: Inadequate clinical response to therapy. NOTE: if it was determined that the primary site of infection required additional antibiotic treatment, the Assessment of Clinical Response had to be a “Failure.”
    2).Overall Therapeutic Response: Subjects who were deemed both clinically cured and microbiologically eradicated were
    considered overall cures.
    3).Microbiologic Response: For each Gram-positive pathogen and each infection, "eradicated" or "presumed eradicated" will be considered as a satisfactory microbiologic response. "Persisted," "presumed persisted," or a positive culture for a Superinfecting Pathogen (Gram-positive) at EOT through TOC will be considered as an unsatisfactory microbiologic response.
    Microbiological success: All Baseline Infecting pathogens were Eradicated or Presumed Eradicated and no Superinfecting pathogen(s) (Gram-positive) were isolated post therapy.
    Microbiological failure: Presence of a Persisting Pathogen or a Superinfecting pathogen (Gram-positive) post therapy (EOT through TOC).
    Overall success:
    This will be based on microbiologic response and clinical response at TOC (cure, improved, failure or nonevaluable) with
    regard to the Investigator’s determination of the resolution or improvement of signs and symptoms.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1). Evaluation of Post-therapy clinical response was determined at the Baseline, EOT, and TOC Visits
    2). The assessment of Overall Therapeutic Response was made at the TOC visit.
    3). Evaluation of Microbiologic Response was determined at EOT through TOC.
    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 Yes
    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) 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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    evaluator-blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of Care
    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 Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    India
    Panama
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months1
    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: 389
    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) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 279
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 110
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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
    Children
    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 389
    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
    G.4 Investigator Network to be involved in the Trial: 1
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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