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    Summary
    EudraCT Number:2015-002781-23
    Sponsor's Protocol Code Number:DAP-PEDS-07-02
    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 number2015-002781-23
    A.3Full title of the trial
    An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged Two to Six Years Who are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Gram-positive Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetic and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections
    A.4.1Sponsor's protocol code numberDAP-PEDS-07-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00679835
    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 Phamaceuticals, 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 pointMedical Director
    B.5.3 Address:
    B.5.3.1Street Address65 Hayden Avenue
    B.5.3.2Town/ cityLexington
    B.5.3.3Post code 02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number781-860-8660
    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 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 namedaptomycin
    D.3.4Pharmaceutical form Injection
    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/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    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 Yes
    D.3.11.13.1Other medicinal product typedaptomycin
    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
    Gram-positive Infection
    E.1.1.1Medical condition in easily understood language
    Skin infection
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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
    The primary objective of this study was to evaluate single-dose pharmacokinetic (PK) data on intravenous (i.v.) daptomycin administered at 8 mg/kg as a 1 hour infusion or 10 mg/kg as either a 1 or 2 hour infusion in pediatric subjects aged 2 to 6 years, inclusive, with proven or suspected Gram-positive infection who were receiving standard antibiotic therapy.
    E.2.2Secondary objectives of the trial
    The secondary objective was to assess the safety of an 8 or 10 mg/kg single dose of i.v. daptomycin administration as either a 1 or 2 hour infusion in pediatric subjects aged 2 to 6 years, inclusive, with proven or suspected Gram-positive infection who were receiving standard antibiotic therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female subjects between the ages of 2 and 6 years old, inclusive, with suspected or diagnosed Gram-positive infection for which the subject was receiving standard antibiotic therapy were specific candidates for the study. Subjects were required to be clinically stable with no evidence of hemodynamic instability in the 72 hour window prior to enrollment and no history or evidence of renal or hepatic compromise, with calculated creatinine clearance rate (CLcr) 80 mL/min/1.73 m2 as determined by the Schwartz equation, CPK levels <2X upper limit of normal (ULN), and presence of 2 patent i.v. lines (or comparable means of venous access) prior to dosing on Study Day 1.
    E.4Principal exclusion criteria
    Subjects were to be excluded from the study if they met any of the following criteria:
    1. Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry;
    2. Known allergy/hypersensitivity to daptomycin
    3. History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma was acceptable), gastrointestinal, endocrine, hematologic, autoimmune disease or primary immune deficiency;
    4. Pneumonia as sole Gram-positive infection being treated with standard antibiotics;
    5. Subjects with clinically significant abnormal laboratory test results (including ECGs), as determined by Investigator;
    6. Administration of rifampin within 7 days of study drug administration;
    7. Body mass index (BMI) that was outside of the 5th to 95th percentile;
    8. Subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of Investigator);
    9. History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system or seizure disorder;
    10. Administration of intramuscular (IM) injection between baseline and study drug administration or expected IM injection within 24 hours following dosing;
    11. Expected surgical procedure(s) within 24 hours prior to and following dosing;
    12. Unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barré or spinal cord injury;
    13. History of or current rhabdomyolysis.
    E.5 End points
    E.5.1Primary end point(s)
    Blood samples for determination of the plasma PK profile of daptomycin
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood samples for determination of the plasma PK profile of daptomycin were to be obtained at 8 time points: 0 minutes (prior to infusion), 30 minutes (during infusion), 60 minutes (within 2 minutes following the end of 1 hour infusion or during the 2 hour infusion), 120 minutes (within 2 minutes following the end of the 2 hour infusion), 4, 7, 12, and 24 hours relative to the start of the infusion.
    E.5.2Secondary end point(s)
    A treatment-emergent adverse event (TEAE) was an AE that occurred during a defined period of the study that was new in onset, or was a preexisting condition that was aggravated in severity or frequency.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The entire study period
    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 No
    E.6.5Efficacy No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    PK and Safety
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    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: 12
    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: 12
    F.1.1.6Adolescents (12-17 years) No
    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 No
    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 No
    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 12
    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
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