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    Summary
    EudraCT Number:2012-003857-26
    Sponsor's Protocol Code Number:BIRT
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-12-07
    Trial 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-003857-26
    A.3Full title of the trial
    The Bacteriuria In Renal Transplantation study: A prospective, randomized, multicenter trial comparing antibiotics versus no treatment in the prevention of urinary tract infection in kidney transplant reicipients with asymptomatic bacteriuria.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Should we treat asymptomatic bacteriuria in kidney transplant recipients? A prospective, randomized, multicenter trial.
    A.3.2Name or abbreviated title of the trial where available
    BIRT
    A.4.1Sponsor's protocol code numberBIRT
    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 SponsorULB ERASME HOSPITAL
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportrenal transplantation clinic in Erasmus
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationULB ERASME HOSPITAL
    B.5.2Functional name of contact pointD.JULIEN COUSSEMENT
    B.5.3 Address:
    B.5.3.1Street Address808 LENNIKSTREET
    B.5.3.2Town/ citybrussels
    B.5.3.3Post code1070
    B.5.3.4CountryBelgium
    B.5.4Telephone number322555.35.32
    B.5.5Fax number322555.35.32
    B.5.6E-mailjulien.coussement@erasme.ulb.ac.be
    D. IMP Identification
    D.IMP: 1
    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 standard of care. Patients will receive standard of care which is defined as antibiotics. The antibiotic drug will be chosen by the local study investigator according to the urine results. No antibiotic is specified in the protocol.
    D.2.1.1.2Name of the Marketing Authorisation holdernot applicable
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 namenot applicable
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNot mentioned (Noncurrent)
    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
    Asymptomatic bacteriuria after renal transplantation.
    Bactériurie asymptomatique après transplantation rénale.
    E.1.1.1Medical condition in easily understood language
    Asymptomatic bacteriuria after renal transplantation.
    Bactériurie asymptomatique après transplantation rénale.
    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
    the main objective of the study is to assess the incidence of a first episode of symptomatic urinary tract infection in kidney transplant recipients with asymptomatic bacteriuria.
    E.2.2Secondary objectives of the trial
    1. to compare the incidence of a first episode of pyelonephritis in both group.
    2. to compare the proportion of patients with clearance of asymptomatic bacteriuria in both group.
    3.to assess the occurence of new episodes of asymptomatic bacteriuria;
    4. to assess the graft function/survival.
    5. to assess the patient survival.
    6. to assess the utility of a control urine culture for diagnosis of asymptomatic bacteriuria in kidney transplant recipients.
    7. to assess the incidence of bacterial resistances
    8. to assess the total number of days of antimicrobial therapy.
    9. to assess the cost of antimicrobial treatment for asymptomatic bacteriuria and symptomatic urinary tract infection
    10. to assess the number of hospitalizations for asymptomatic bacteriuria and symptomatic urinary tract infection treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    asymptomatic bacteriuria in kidney transplant recipients after first two months post transplantation
    asymptomatic bacteriuria is define as isolation of a single bacterial species in a quantitative count>= 100.000 CFU/ml in a single collected urine specimen from a patient without biological or clinical signs or symptoms referable to urinary tract infection.
    E.4Principal exclusion criteria
    1. Pregnant women or women who wish to become pregnant during the course of the study
    2. Presence of indwelling urinary devices such as urethral catheter, ureteral catheter, nephrostomy and/or suprapubic catheter
    3. Combined transplantation (liver-kidney, lung-kidney, heart-kidney)
    4. Urinary tract surgery during the last two months
    5. Surgical urological procedure planned in the next two weeks
    6. Neutropenia (<= 500/mm3)
    7. Important intensification of immunosuppression (Solumedrol bolus and/or use of thymoglobulin) or any other treatment of an acute graft rejection in the last two months
    8. Use of antibiotics at the time of asymptomatic bacteriuria (except for prevention of pneumocystis jiroveci)
    9. End Stage Renal Disease requiring dialysis
    10. Non-functionning native bladder (e.g. bladder dysfunction requiring intermittent self-catheterization, orthotopic ileal bladder)
    11. Recurrent pyelonephritis (>= 2 episodes in the last year)
    12. kidney transplant recipients who could not return for regular follow-up
    E.5 End points
    E.5.1Primary end point(s)
    Symptomatic urinary tract infection.

    Symptomatic urinary tract infection is defined as:
    - Association of a positive urinalysis (>= 10.000 CFU/mL) with presence of signs or symptoms attributable to urinary tract infection. Clinical signs depend on the urinary tract infection, which can present as acute cystitis, acute pyelonephritis or acute prostatitis
    - (in the absence of clinical signs of urinary tract infection) positive urine culture (>= 100.000 CFU/mL) associated with fever and/or rigors and with an inflammatory syndrome unexplained by another cause (CRP level > 3 mg/dL).

    Pyuria is necessary for diagnosis of symptomatic urinary tract infection.
    E.5.1.1Timepoint(s) of evaluation of this end point
    M0 (baseline), M1 (one month after study inclusion), M2 (two months after study inclusion), M4, M6, M8, M10 and M12.
    E.5.2Secondary end point(s)
    Serum creatinine. Creatinine clearance. Graft survival. Patient survival. Asymptomatic bacteriuria clearance. Bacterial resistances. Graft rejection. Antibiotics cost. Hospitalizations cost.
    E.5.2.1Timepoint(s) of evaluation of this end point
    M0 (baseline), M1 (one month after study inclusion), M2 (two months after study inclusion), M4, M6, M8, M10 and M12.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Antibiotics (standard of care, at the discretion of the physician)
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 130
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 130
    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.4.1In the member state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 130
    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)
    Not applicable. After the end of the study, the patient will be treated according to center practices.
    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 Decision2013-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-11
    P. End of Trial
    P.End of Trial StatusOngoing
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