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    Summary
    EudraCT Number:2009-015953-18
    Sponsor's Protocol Code Number:DORIPED3002
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2010-05-20
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2009-015953-18
    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 Complicated Urinary Tract Infections
    A.4.1Sponsor's protocol code numberDORIPED3002
    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 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 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 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 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 INNDORIPENEM MONOHYDRATE
    D.3.9.1CAS number 364622-82-2
    D.3.9.2Current sponsor codeJNJ-38174942
    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) 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 No
    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 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 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.3.9.3Other 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 number1
    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) 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 No
    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
    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
    Complicated Urinary Tract Infections
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10046571
    E.1.2Term Urinary tract infection
    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 profile of doripenem compared with that of cefepime in hospitalized children 3 months to <18 years of age with cUTI.
    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 TOC visit
    •To determine the favorable microbiological response rate of doripenem compared with that of cefepime at the TOC visit
    •To determine the clinical improvement rate of doripenem compared with that of cefepime at the end of treatment with IV study drug therapy (EIV) visit
    •To determine the favorable microbiological response rate of doripenem compared with that of cefepime at the EIV visit
    •To determine the sustained clinical cure rate of doripenem compared with that of cefepime at the late follow-up (LFU) visit
    •To determine the favorable microbiological response rate of doripenem compared with that of cefepime at the LFU visit
    •To characterize the pharmacokinetics of doripenem in hospitalized children with cUTI based on a sparse pharmacokinetic sampling scheme
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Boy or girl 3 months to <18 years of age, inclusive
    •Have a current episode of cUTI as indicated by the following clinical signs or symptoms:
    –Complicated UTI
    Infants 3 months to <2 years of age
    –Presenting with at least one of the following signs or symptoms:
    Recent weight loss
    Failure to thrive
    Abdominal pain
    Vomiting
    Diarrhea
    Irritability
    Poor feeding
    Lack of normal level of activity
    Jaundice, or
    Fever (oral temperature >=38.0 degrees C or equivalent by an alternative method). Refer to Attachment 1, Oral Temperature Conversion Table for oral temperature equivalents by alternative methods
    –AND has at least 1 complicating factor (see below)
    Children 2 to <18 years of age
    –Presenting with at least one of the following signs or symptoms:
    Dysuria
    Urinary frequency
    Urgency
    Suprapubic or abdominal pain
    Secondary urinary incontinence, or
    Fever (oral temperature >=38.0 degrees C or equivalent by an alternative method). Refer to Attachment 1, Oral Temperature Conversion Table for oral temperature equivalents by alternative methods
    –Note: subjects who are not able to perceive dysuria, urinary frequency, urgency, or suprapubic or abdominal pain due to congenital or acquired spinal cord injury will be allowed to enroll with the diagnosis of “asymptomatic cUTI” but are required to provide 2 study-qualifying baseline urine cultures from urine specimens obtained at least 1 hour apart (see Section 9.4, Criteria for Study Qualifying Pretreatment Baseline Urine Culture for further details)
    –AND have at least 1 complicating factor (see below)
    Complicating Factors for All Age Categories (3 months to <18 years of age)
    –Include at least one of the following complicating factors:
    Current bladder instrumentation or presence of an indwelling catheter that is anticipated to be removed during the course of IV study drug therapy
    Use of intermittent catheterization
    Urogenital surgery within the 7 days before administration of the first dose of IV study drug
    Known functional or anatomic abnormality of the urogenital tract
    Obstructive uropathy
    Vesicoureteral reflux
    Neurogenic disturbances of micturation with significant impact on bladder emptying
    Recurrent UTI (defined as 2 or more previous UTIs within a 12-month period), or
    Evidence that the current UTI may be caused by a resistant uropathogen (including evidence that the current episode is a breakthrough infection or in a child on chronic antimicrobial suppression with unresolved vesicoureteral reflux), or
    If this is the initial UTI episode in a child 3 months to <2 years of age, the child is suspected of having an acquired or congenital structural or functional urologic abnormality
    –Pyelonephritis:
    Children >2 years of age
    –Presenting with at least one of the following signs or symptoms:
    Fever (oral temperature >=38.0 degrees C or equivalent by an alternative method). Refer to Attachment 1, Oral Temperature Conversion Table for oral temperature equivalents by alternative methods); and at least one of the following:
    nausea or vomiting
    costovertebral angle tenderness or flank pain
    •Have a positive urinalysis (urine specimen positive for nitrite and leukocyte esterase via urine dipstick or urinalysis)
    •Have a study-qualifying pretreatment “baseline” urine culture specimen obtained by an acceptable method including SPA, clean urethral catheterization, indwelling urethral catheter, or mid-stream clean catch (urine specimens obtained from urine bags will not be allowed) (see Section 9.5, Urine Collection Procedures) within 48 hours before the start of the administration of the first dose of IV study drug therapy from which a bacterial uropathogen is isolated with a growth of >=10^5 CFU/mL (see Section 9.4, Criteria for Study Qualifying Pretreatment Baseline Urine Culture). (Note: Subjects may be enrolled into the study before the results of the pretreatment urine culture are known. However, if the baseline urine culture results do not meet the definition of a study-qualifying pretreatment baseline urine specimen as described in Section 9.4, Criteria for Study-Qualifying Pretreatment Baseline Urine Culture, the subject must discontinue study drug therapy although he or she will remain in the study for safety follow up).
    •Must, based on the judgment of the investigator, require 10 to 14 days of antibacterial therapy for the treatment of the presumed cUTI. (Note that the subject must require at least 3 days of IV antibiotic therapy initially).
    E.4Principal exclusion criteria
    •Have a history of hypersensitivity reactions to carbapenems, cephalosporins, penicillins, or other beta-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 beta-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.
    •Concomitant infection including but not limited to suspected or confirmed meningitis or central nervous system infection requiring systemic antibiotic or antifungal therapy in addition to the IV study drug therapy at the time of randomization. (Clarification: possible bacteremia with the presumed same urinary pathogen is acceptable).
    •Receipt of any amount of potentially therapeutic antibiotic for the treatment of the current UTI within 96 hours before obtaining the study-qualifying pretreatment baseline urine. (Exception: Subjects receiving oral antibiotics for UTI prophylaxis and are suspected to have a breakthrough UTI are eligible to enroll if all other eligibility criteria are met including obtaining a study-qualifying pretreatment baseline urine culture).
    •Have received systemic antibiotic therapy for more than 24 hours since obtaining the study-qualifying pretreatment baseline urine specimen
    •Intractable UTI/pyelonephritis infection anticipated to require more than 14 days of study drug therapy
    •Have a permanent indwelling bladder catheter or instrumentation including nephrostomy
    •Current urinary catheter that will not be removed or anticipation of urinary catheter placement that will not be removed during the course of IV study drug therapy administration. (Clarification: Intermittent straight catheterization after the IV study drug therapy administration period is acceptable).
    •Complete, permanent obstruction of the urinary tract
    •Confirmed fungal UTI with a colony count >=10^3 CFU/mL
    •Suspected or confirmed perinephric or intrarenal abscess
    •Suspected or confirmed prostatitis
    •Known ileal loops
    •Girls who are pregnant or are nursing a child or are menarchal, and, if sexually active, are not practicing a highly effective method of birth control (eg, prescription hormonal contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method, eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel, male partner sterilization) as local regulations permit, before screening and agree to continue using a highly effective method of birth control (as previously described) for 30 days after administration of the last dose of study drug therapy. Note: for all menarchal girls, confirm a negative urine or serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening, before enrolling the subject into the study.
    •Have any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure, respiratory failure, or septic shock, or require vasopressor therapy if hemodynamically unstable (volume repletion for support of blood pressure without the use of pressers is allowed), or are considered unlikely to survive for the duration of the study for any other reason (approximately 7 to 8 weeks)
    •The subject has any of the following clinically significant laboratory abnormalities:
    –Absolute neutrophil count (ANC) <500 cells/microlitre
    –Platelet count <40,000 cells/microlitre
    –Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin >5x the age-specific upper limit of normal (ULN)
    –Acute or chronic renal insufficiency with a baseline CLcr <60 mL per minute or requires dialysis therapy for any reason.
    •Are profoundly immunodeficient and require prophylactic antimicrobial therapy for Pneumocystis jirovicei, Toxoplasma gondii, or herpes viruses, and/or chronic or intermittent inmunoglobin replacement therapy
    •Are receiving chemotherapy for current malignancy
    •Have received an organ or bone marrow transplant and are treated with chronic immunosuppressive therapy for prevention of organ transplantation rejection
    •Are receiving imuran, methotrexate, or chronic corticosteroid therapy equivalent to >=1 mg/kg of prednisone daily for the 30 days before randomization
    •Have a history of uncontrolled epilepsy
    •Are currently receiving probenecid or valproic acid
    E.5 End points
    E.5.1Primary end point(s)
    A subject will be considered to have completed the study if he or she has received at least a partial dose of study drug therapy and completed the LFU visit. Subjects who prematurely discontinue study treatment will also be considered to have completed the study after the LFU visit.
    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 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 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) 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 concerned2
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days18
    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) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    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 months to <18 year of age.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 49
    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 Decision2010-09-03
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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