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    Summary
    EudraCT Number:2022-002319-43
    Sponsor's Protocol Code Number:APHP200020
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-08-23
    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 ConcernedFrance - ANSM
    A.2EudraCT number2022-002319-43
    A.3Full title of the trial
    Efficacy of 7 days versus 14 days of antibiotic therapy for acute pyelonephritis in kidney transplant recipients, a multicentre randomized non-inferiority trial.
    Efficacité d'une antibiothérapie de 7 jours comparée à 14 jours pour traiter une pyélonéphrite aiguë chez les transplantés rénaux, essai multicentrique randomisé de non-infériorité.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of 7 days versus 14 days of antibiotic therapy for acute pyelonephritis in kidney transplant recipients
    Efficacité d'une antibiothérapie de 7 jours comparée à 14 jours pour traiter une pyélonéphrite aiguë chez les transplantés rénaux
    A.3.2Name or abbreviated title of the trial where available
    SHORTCUT
    SHORTCUT
    A.4.1Sponsor's protocol code numberAPHP200020
    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 SponsorAssistance Publique - Hôpitaux de Paris
    B.1.3.4CountryFrance
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique - Hôpitaux de Paris
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street AddressHôpital Saint-Louis - 1 av., Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number0033144841732
    B.5.5Fax number0033144841701
    B.5.6E-maillaura.blanchet@aphp.fr
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namebeta-lactamine
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Intravenous use
    Oral use
    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 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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameFluoroquinolones
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Oral use
    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: 3
    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 cotrimoxazole
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namecotrimoxazole
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Oral use
    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: 4
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameAminoside
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Intravenous use
    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: 5
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Oral use
    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
    Kidney Transplant recipient with acute pyelonephritis
    Patients transplantés rénaux ayant une pyélonéphrite aiguë
    E.1.1.1Medical condition in easily understood language
    Acute pyelonephritis
    Pyélonéphrite aïgue
    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
    To show that a 7 day-antibiotic therapy is not inferior to a 14 day-antibiotic therapy in the treatment of acute pyelonephritis in kidney transplant recipients.
    Montrer qu'une antibiothérapie de 7 jours n'est pas inférieure à une antibiothérapie de 14 jours dans le traitement de la pyélonéphrite aiguë chez les transplantés rénaux.
    E.2.2Secondary objectives of the trial
    o compare between both arms:
    -Clinical and microbiological efficacy at day 90 and day 180
    -Tolerance and safety of antibiotics
    -Hospitalisation length stay
    -Antibiotic consumption during total follow up
    -Acquisition of antibiotic resistant Enterobacteriaceae
    -Kidney graft function and transplant rejection at day 90 and day 180
    - The total costs.
    To evaluate risk factors for failure and relapse.
    Comparer entre les deux bras :
    o L'efficacité clinique et microbiologique à J 90 et à J 180.
    o La tolérance des antibiotiques
    o La durée de séjour à l'hôpital
    o La consommation d'antibiotiques pendant la durée totale du suivi.
    o L’acquisition d'entérobactéries résistantes aux antibiotiques.
    o La fonction du greffon rénal à J 90 et à J 180.
    o Les coûts totaux.
    Évaluer les facteurs de risque d'échec et de rechute.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age >18 years KTR
    -APN defined by: fever (T°≥38°C) (with or without clinical signs and/or symptoms of UTI) and pyuria (≥10.4 white blood cells/mL) and positive urine culture (single uropathogen ≥10.3 CFU/mL susceptible to the empirically administrated antibiotic)
    -No confirmed or suspected febrile non urinary bacterial infection
    -No urologic/renal complication at baseline imaging (abscess, obstruction...)
    - Early response after 48h of antibiotic treatment defined by: T°<38°C and improvement or complete resolution of any symptoms and/or signs of UTI if present at baseline 48 to 60 hours after the first administration of effective antibiotic.
    - Written informed consent
    -Age >18 ans
    -Transplanté rénal
    -PNA définie par : fièvre (T°≥38°C) (avec ou sans signes cliniques et/ou symptômes d'infection urinaire) et pyurie (≥10,4 globules blancs/mL) et culture d'urine positive (uropathogène unique ≥10,3 UFC/mL sensible
    à l'antibiotique administré empiriquement).
    -Aucune infection bactérienne fébrile non urinaire confirmée ou suspectée.
    -Pas de complication urologique/rénale à l'imagerie (abcès, obstruction...).
    -Réponse précoce après 48h de traitement antibiotique définie par : T°<38°C et amélioration ou résolution complète de tous les symptômes et/ou signes d'infection urinaire s'ils étaient présents au départ 48 à 60 heures après la première administration d'un antibiotique efficace.
    -Consentement éclairé signé
    E.4Principal exclusion criteria
    Patients with any of the following conditions:
    -Severe or complicated
    - Any rapidly progressing disease or immediately life-threatening illness, including, but not limited to, septic shock, current or impeding respiratory failure, acute heart or liver failure
    - Admission or stay in intensive care unit at baseline
    - Obstruction of the urinary tract
    - Renal, perinephric or prostatic abscess
    - prior inclusion in this study
    - current participation to another interventional study
    -Dual therapy (only 1 dose of aminoside is allowed before randomization)
    -First month post transplantation
    -Current indwelling catheter (including bladder catheter, ureteral stents, percutaneous nephrostomy tubes)
    -Neurogenic bladder
    -Enterocystoplasty
    -Immunodeficiency or immunosuppressive therapy not related to kidney transplantation, including hematologic malignancy, cancer, asplenia, neutropenia<500 PNN/mm3,
    -Pregnancy, breastfeeding
    -Hypersensitivity or previous severe adverse drug reaction to the antibiotic therapy
    -Unable or unwilling, in the judgment of the investigator, to comply with the protocol
    -Life expectancy<1 month
    -Patient under legal guardianship or without healthcare coverage
    -Homeless patient
    Patients se présentant dans l’une des situations suivantes :
    - Affection/PNA sévère ou compliquée
    -Toute maladie à progression rapide ou mettant immédiatement le pronostic vital en jeu, y compris, mais sans s'y limiter, un choc septique, une insuffisance respiratoire, une insuffisance cardiaque ou hépatique aiguë.
    - Admission ou séjour dans une unité de soins intensifs au début de l'étude
    -Obstruction des voies urinaires
    -Abcès rénal, périrénal ou prostatique.
    - Inclusion antérieure dans cette étude
    -participation actuelle à une autre étude interventionnelle
    -bi-antibiothérapie pour la PNA (une seule dose d'aminoside est autorisée avant la randomisation)
    -Premier mois après la transplantation
    -Cathéter à demeure (y compris cathéter vésical, stents urétraux, néphrostomie percutanée).
    - Vessie neurogène
    -Entérocystoplastie
    -Immunodéficience ou traitement immunosuppresseur non lié à la transplantation rénale, y compris hémopathie maligne, cancer, asplénie, neutropénie<500 PNN/mm3,
    -Grossesse, allaitement
    -Hypersensibilité ou réaction indésirable grave antérieure à l'antibiothérapie.
    -Incapacité ou refus, selon le jugement de l'investigateur, de se conformer au protocole.
    -Espérance de vie<1 mois
    -Patient sous tutelle ou sans couverture médicale.
    -Patient sans domicile fixe
    E.5 End points
    E.5.1Primary end point(s)
    Clinical cure and microbiological eradication and no additional antibiotic treatment since the end of antibiotic treatment up to the main evaluation at day 30.
    Clinical cure is defined as fever <38°C and no symptoms of UTI.
    Microbiological eradication is defined as uropathogen ≤ 10.3 CFU/mL in urine culture
    Guérison clinique* et éradication microbiologique** et aucun traitement antibiotique supplémentaire depuis la fin du traitement antibiotique jusqu'à l'évaluation principale à J 30.
    *La guérison clinique est définie par une fièvre <38°C et l'absence de symptômes d'infection urinaire.
    **L'éradication microbiologique est définie comme un uropathogène ≤ 10,3 UFC/mL dans la culture d'urine.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 30
    Jour 30
    E.5.2Secondary end point(s)
    Clinical cure and microbiological eradication at day 90 and 180
    - Incidence of relapse /recurrence between day 30 and day 90
    - Incidence of adverse events imputable to antibiotic treatment
    - MDRD (Modification of Diet in Renal Disease) and CKD (Chronic Kidney Disease - Epidemiology Collaboration) epi at day 90 and day 180
    - Hospitalisation length stay defined by the delay between the date of inclusion and the date of hospital discharge
    - Antibiotic consumption
    - Rectal carriage of antibiotic resistant Enterobacteriaceae at day 30
    La guérison clinique et l'éradication microbiologique à J 90 et J 180.
    L’incidence des rechutes/récidives entre J30 et J90
    L’incidence des effets indésirables imputables au traitement antibiotique
    La consommation d'antibiotiques
    Le portage rectal d'entérobactéries résistantes aux antibiotiques à J30.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 180
    Jour 180
    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 No
    E.6.5Efficacy Yes
    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 No
    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
    durée de traitement de 14 jours
    14-day treatment period
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States No
    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
    Dernière visite dernier patient
    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 months42
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months42
    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: 470
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 470
    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 state470
    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)
    Standard of care
    soins standard
    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 Decision2022-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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