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    The EU Clinical Trials Register currently displays   43936   clinical trials with a EudraCT protocol, of which   7310   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:2009-016069-27
    Sponsor's Protocol Code Number:DORIPED3003
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-11-24
    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
    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 ConcernedLatvia - SAM
    A.2EudraCT number2009-016069-27
    A.3Full title of the trial
    A Prospective, Randomized, Double-Blind, Multicenter Study to
    Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety and Tolerability Study of Doripenem Compared with Cefepime in Hospitalized Children with Bacterial Pneumonia
    A.4.1Sponsor's protocol code numberDORIPED3003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01110421
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/192/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
    B.1.3.4CountryBelgium
    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 supportJohnson & Johnson Pharmaceutical Research &
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen- Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressJanssen Biologics BV - Clinical Registry Group - Archimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code233CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715242166
    B.5.5Fax number+31715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 Yes
    D.2.1.1.1Trade name DORIBAX
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 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 INNDORIPENEM MONOHYDRATE
    D.3.9.1CAS number 364622-82-2
    D.3.9.2Current sponsor codeJNJ-38174942
    D.3.9.3Other descriptive nameDORIPENEM
    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.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 MAXIPIME
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 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.3.9.3Other descriptive nameCEFEPIME DIHYDROCHLORIDE MONOHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bacterial Pneumonia
    E.1.1.1Medical condition in easily understood language
    Pneumonia, Bacterial
    Community-Acquired Infections
    Nosocomial Infection
    Pneumonia, Ventilator-Associated
    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 LLT
    E.1.2Classification code 10004051
    E.1.2Term Bacterial pneumonia, unspecified
    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 establish the safety and tolerability of doripenem compared with that of cefepime in hospitalized children 3 months to <18 years of age with suspected bacterial pneumonia including NP (Nosocomial Pneumonia), VAP (Ventilator-Assiociated Pneumonia), and severe CAP (Community-Acquired Pneumonia).
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    •To determine the clinical cure rate of doripenem compared with that of cefepime at the test-of-cure (TOC) visit
    •To determine the clinical improvement rate of doripenem compared with that of cefepime at the end-of-treatment for IV study drug therapy (EIV) visit
    •To determine the clinical relapse rate of doripenem compared with that of cefepime at the late follow-up (LFU) visit
    •To characterize the pharmacokinetics of doripenem in hospitalized children with pneumonia based on a sparse pharmacokinetic sampling scheme
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 - Have new or progressive radiographic infiltrate(s) (alveolar, lobar, or consolidation) consistent with a bacterial pneumonia that is not related to cardiac or other disease processes. (Note: subjects with clinically significant pleural effusions may be included if an empyema has been ruled out by a diagnostic sampling of pleural fluid. Chest X-rays obtained within 48 hours before the start of the infusion of the first dose of IV study drug therapy are acceptable for the screening examination. A computed tomography (CT) scan/magnetic resonance imaging (MRI) may be used to supplement a chest X-ray if the chest X-ray is not sufficiently interpretable).
    2 - Have a clinical presentation compatible with bacterial pneumonia with ALL of the
    following:
    o Fever (oral temperature >38.0C, tympanic temperature >38.3C, or rectal or core temperature >38.8C) or hypothermia (rectal or core temperature <35.0C) AND
    o Leukocytosis defined as WBC count > or = 15,000 cells/μL OR > or = 15% immature neutrophils, regardless of the total peripheral white cell count OR neutrophil count >1.2 times (x) the upper limit of normal (ULN); OR leucopenia with total WBC count <4500 cells/μL AND
    o Non-intubated subjects must have at least 2 of the following clinical signs or symptoms:
    – Cough
    – New onset of LRT secretions, change in character of secretions, or increase in the quantity of secretions or suctioning requirements
    – Auscultatory findings of pneumonia or consolidation (rales, rhonchi bronchial breath sounds, decreased breath sounds, wheezing, egophony)
    – Dyspnea
    – Increased work of breathing expressed as presence of retractions, nasal flaring, or grunting
    – Hypoxemia (partial pressure of oxygen (PO2) <60mm Hg on room air) or oxygen saturation less than 90% on room air
    – Tachypnea defined as follows:
    > or = 50 breaths/minute for ages > or = 3 months to < or = 12 months
    > or = 40 breaths/minute for ages >12 months to < or = 5 years
    > or = 20 breaths/minute for ages >5 years of age
    OR
    apnea in infants <12 months of age
    3 - Have a diagnosis of NP ,VAP, or severe CAP defined by the disease-specific criteria
    specified below:
    Nosocomial Pneumonia:
    Subjects with NP must not be intubated or mechanically ventilated and must be hospitalized or reside in a chronic care facility for a minimum of
    48 hours before being diagnosed with pneumonia.
    Ventilator-associated pneumonia:
    Subjects with VAP must be intubated and mechanically ventilated for > or = 48 hours before being diagnosed with pneumonia.
    Severe community-acquired pneumonia:
    Subjects with severe CAP must have pneumonia that is neither NP or VAP and must have at least ONE of the following risk factors for more severe disease or infection with a less susceptible pathogen:
    – a mild to moderately immunocompromised condition including but not limited to diabetes or other metabolic disorder associated with immunosuppression, asplenia, sickle cell disease, mild to moderate neutropenia (ANC of 500 – 1500 cells/mm3), HIV infection not requiring Pneumocystis jirovicei prophylaxis, antibody deficiency syndromes not requiring chronic immunoglobulin replacement therapy, T-cell deficiencies not requiring prophylactic antibiotics or other chronic therapy for the immunodeficiency, phagocytic disorders, and receipt of non-inhaled corticosteroid therapy equivalent to <1 mg/kg of prednisone daily for 14 or more days during the 30 days before randomization,
    – a documented tracheoesophageal fistula, or oropharyngeal incoordination with swallowing dysfunction predisposing to aspiration syndrome
    – gastroesophageal reflux documented by either barium swallow or pH manometry,
    – a condition associated with significant respiratory muscle dysfunction including but not limited to congenital or acquired cervical spinal cord defects, spinal muscular atrophy, peripheral nerve neuromuscular junction defects, and muscular dystrophies or myopathies,
    – a congenital cardiac defect involving left to right shunting or a patent ductus arteriosus,
    – prior admission to a health care facility (either a hospital, overnight acute care setting, or chronic care facility) for more than 24 consecutive hours during the 30 days before randomization,
    – receipt of more than 24 consecutive hours of systemic (IV, IM or oral) antibacterial therapy for treatment of infection other than the current episode of pneumonia during the 30 days before randomization
    – suspected gram negative pathogen causing pneumonia.
    4 - Must, based on the judgment of the investigator, require hospitalization initially and
    antibacterial therapy for 10 to 14 days for the treatment of the current pneumonia. (Note that the subject must require at least 3 days of IV antibiotic therapy initially).
    E.4Principal exclusion criteria
    1 - Have a history of hypersensitivity reactions to carbapenems, cephalosporins, penicillins, or other β-lactam antibiotics. Note: Subjects with a history of mild non-urticarial skin rash temporally related to but considered not associated with the previous use of β-lactam antibiotics are permitted to enroll in the study. For such subjects, there must be a description of the rash and documentation by the investigator that upon review of the history it is his/her opinion that the rash was unlikely due to any of the above-mentioned classes of drugs for the subject to qualify for inclusion in the study.
    2 - Concomitant infection including but not limited to suspected or confirmed meningitis, or other CNS infection, requiring systemic antibiotic or antifungal therapy at the time of randomization. (Clarification: possible bacteremia with a presumed respiratory pathogen is acceptable).
    3 - Have received more than 24 hours of systemic antibacterial therapy in the 48 hours before the start of the infusion of the first dose of IV study drug therapy.
    4 - Known presence at baseline of Stenotrophomonas maltophilia or Burkholderia cepacia pulmonary infection
    5 - Known at the time of randomization to have mono-microbial pneumonia caused by a single pathogen that is nonsusceptible to doripenem or cefepime, including but not limited to MRSA or atypical bacteria.
    6 - Have acute respiratory distress syndrome (defined by either diffuse bilateral radiographic infiltrates and/or a PaO2 to fraction of inspired oxygen (FiO2) ratio of <200)
    7 - Acute or chronic renal insufficiency with a baseline CLCR <60 mL/minute or requires dialysis therapy for any reason.
    8 - Are profoundly immunodeficient and require prophylactic antimicrobial therapy to
    prevent infection with Pneumocystis jirovicei, Toxoplasma gondii, or herpes viruses,
    and/or required chronic or intermittent immunoglobulin replacement therapy.
    E.5 End points
    E.5.1Primary end point(s)
    1 - Changes in adverse events
    2 - Clinical laboratory tests
    3 - Vital signs measurements
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 - Baseline up to 42 days after the last dose of study drug
    2 - Baseline up to 42 days after the last dose of study drug
    3 - Baseline up to 42 days after the last dose of study drug
    E.5.2Secondary end point(s)
    1 - To determine the clinical cure rate of doripenem compared with that of cefepime at the test of cure (TOC) visit
    2 - To determine the clinical improvement rate of doripenem compared with that of cefepime at the end of treatment for IV study drug therapy (EIV) visit
    3 - To determine the clinical relapse rate of doripenem compared with that of cefepime at the late follow-up (LFU) visit
    4 - To characterize the pharmacokinetics of doripenem in hospitalized children with pneumonia based on a sparse pharmacokinetic sampling scheme
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - 7 to 14 days after the last dose of iv study drug including oral antibiotic therapy
    2 - Within 24 hours after completion of the last dose of iv study drug
    3 - 28 to 42 days after the last dose of iv study drug including oral antibiotic therapy
    4 - 1, 2, 4 and 6 hours after the 4th, 5th, 6th, or 7th dose administrations of doripenem/doripenem placebo
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Colombia
    India
    Latvia
    Lithuania
    Mexico
    Panama
    Poland
    Uganda
    Ukraine
    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
    End of trial is last visit of the last subject (Late Follow Up visit) (LFU)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days17
    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: 140
    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: 26
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 54
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    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
    Pediatric population: subjects from 3 month to <18 year of age.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 140
    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)
    After the study is over, JnJPRD will not continue to provide the subject with the study medication. The subjects will be followed by the study doctor according to the local standard of care.
    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 Decision2011-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-08-05
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