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    The EU Clinical Trials Register currently displays   42567   clinical trials with a EudraCT protocol, of which   7008   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-002198-44
    Sponsor's Protocol Code Number:P903-21
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-07-22
    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 number2011-002198-44
    A.3Full title of the trial
    Pharmacokinetics of a Single Dose of Ceftaroline
    fosamil in Children Ages Birth to Younger Than 12
    Years With Suspected or Confirmed Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Blood Levels of Ceftaroline fosamil in Children who are
    receiving anitbiotic Therapy in the Hospital
    A.3.2Name or abbreviated title of the trial where available
    Pharmacokinetics of a Single Dose of Ceftaroline fosamil in Children
    A.4.1Sponsor's protocol code numberP903-21
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01298843
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/158/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCerexa, Inc. (subsidary of Forest Laboratories)
    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 supportCerexa, Inc. (subsidary of Forest Laboratories)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCerexa, Inc. (subsidary of Forest Laboratories)
    B.5.2Functional name of contact pointKristina Haeckl
    B.5.3 Address:
    B.5.3.1Street Address2100 Franklin St Suite 900
    B.5.3.2Town/ cityOakland
    B.5.3.3Post code94612
    B.5.3.4CountryUnited States
    B.5.4Telephone number5102859228
    B.5.5Fax number5102859482
    B.5.6E-mailkhaeckl@cerexa.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 nameCeftaroline fosamil
    D.3.4Pharmaceutical form Powder for concentrate for solution for 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 INNceftaroline fosamil for injection
    D.3.9.1CAS number CAS 229016-7
    D.3.9.2Current sponsor codeceftaroline fosamil
    D.3.9.3Other descriptive namePPI-0903, TAK-599, ceftaroline acetate
    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.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
    Pharmacokinetics of a Single Dose of Ceftaroline
    fosamil in Children Ages Birth to Younger Than 12
    Years With Suspected or Confirmed Infection
    E.1.1.1Medical condition in easily understood language
    Infections
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    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
    To evalutate the single-dose pharmacokinetic profile, safety and
    tolerability of ceftaroline fosamil administered by intravenous infusion
    in children with ages from birth to younger than 12 years
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent from parent(s) (or other legally acceptable
    representative[s]) and verbal informed assent from subject (if age
    appropriate; according to local requirements)
    2. Male or female children with ages from birth to younger than 12
    years
    3. Hospitalized and receiving antibiotic therapy for treatment of a
    suspected or confirmed systemic
    4. Negative urine pregnancy test (if female and has reached menarche)
    5. Sufficient intravascular access (peripheral or central) to receive
    study drug
    E.4Principal exclusion criteria
    1. History of any hypersensitivity or allergic reaction to any β-lactam
    antimicrobial (eg, cephalosporins, penicillins)
    2. Past or current history of epilepsy or seizure disorder (excluding
    childhood febrile seizures)
    3. Moderate or severe renal impairment such that: ○ Cohorts 1, and 2 ,
    and 3: Creatinine clearance (CrCl) < 50 mL/min
    calculated using the modified Schwartz equation (Schwartz et al, 1987):
    CrCl (mL/min/1.73m2) = [length (cm) x k] / Serum creatinine
    (mg/dL)
    where:
    - k = 0.45 for infants 1 to 52 weeks old
    - k = 0.55 for children 1 to 12 years old
    ○ Cohorts 4 and 5:
    - Urine output with value of < 1 mL/min/kg (measured in diapered
    children as diaper weight
    change where 1 g = 1 mL of urine) and
    - Serum creatinine value of > 1.3 mg/dL
    Note: For Cohort 3, if calculated CrCl is between 50-60
    mL/min/1.73m2, and the child is age
    24 months or under, please ensure urine output and serum creatinine
    values are within normal or mild renal impairment criteria as for
    Cohorts 4 and 5 (ie, urine output ≥ 1mL/kg/min [measured in diapered
    children as diaper weight change where 1 g = 1 mL of urine] and serum
    creatinine ≤ 1.3 mg/dL)
    4. Aspartate aminotransferase, alanine aminotransferase, or total
    bilirubin level > 3 times upper limit of
    normal (neonates with elevated total bilirubin may participate if
    conjugated bilirubin is normal)
    5. Any condition (eg, septic shock, acute hemodynamic instability
    including those requiring pressor
    support) that would make the subject, in the opinion of the
    Investigator, unsuitable for the study (eg,
    would place a subject at risk or compromise the quality of the data)
    6. Receipt of a blood transfusion during the 24-hour period before
    enrollment
    7. Use of probenecid within 3 days prior to dosing
    8. If female, currently pregnant or nursing
    9. Previous participation in this study or in any study involving
    administration of an investigational agent
    within 30 days prior to enrollment into this study where the subject
    was randomized and received an
    active investigational product (not placebo)
    10. Unwilling or unable to adhere to study procedures or restrictions
    E.5 End points
    E.5.1Primary end point(s)
    The Safety Population (all subjects who receive any amount of
    ceftaroline fosamil)
    PK Analysis Population (all subjects who received the entire
    ceftaroline fosamil infusion on
    Study Day 1 and from whom any PK samples are collected)
    Outcome Variables:
    • Evaluation of pharmacokinetics (Cmax, AUC, clearance and T½ will
    be derived from population PK
    analysis)
    • Plasma concentrations-time profiles of ceftaroline by patient, age
    cohort, and dosage level
    • Evaluation of safety and tolerablility of ceftaroline following a single dose

    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 5 days
    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 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 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) 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? No
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 6
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 6
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 12
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    informed consent from parent(s) or a legal guardian will be obtained
    for each subject. Informed assent will be obtained from subjects
    capable of giving one
    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 56
    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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