Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-006991-18
    Sponsor's Protocol Code Number:2020/0423/HP
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-26
    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 number2021-006991-18
    A.3Full title of the trial
    Postoperative anti-infective strategy following pancreaticoduodenectomy in patients with preoperative biliary stent
    Stratégie anti-infectieuse postopératoire après une duodénopancréatectomie chez les patients ayant un stent biliaire préopératoire
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Postoperative anti-infective strategy following pancreaticoduodenectomy in patients with preoperative biliary stent
    Stratégie anti-infectieuse postopératoire après une duodénopancréatectomie chez les patients ayant un stent biliaire préopératoire
    A.3.2Name or abbreviated title of the trial where available
    FRENCH24 ANIS
    FRENCH24 ANIS
    A.4.1Sponsor's protocol code number2020/0423/HP
    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 SponsorCHU de Rouen
    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 supportChu de Rouen
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Rouen
    B.5.2Functional name of contact pointJulie RONDEAUX
    B.5.3 Address:
    B.5.3.1Street Address1 rue de Germont
    B.5.3.2Town/ cityRouen
    B.5.3.3Post code76031
    B.5.3.4CountryFrance
    B.5.4Telephone number+33232888265
    B.5.6E-mailsecretariat.DRC@chu-rouen.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.2.1.1.1Trade name PIPERACILLINE/TAZOBACTAM PANPHARMA 4 g/500 mg, poudre pour solution pour perfusion
    D.2.1.1.2Name of the Marketing Authorisation holderPANPHARMA
    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 namePIPERACILLINE/TAZOBACTAM PANPHARMA 4 g/500 mg, poudre pour solution pour perfusion
    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.3.11 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.2.1.1.1Trade name METRONIDAZOLE B BRAUN 0,5 %, solution pour perfusion
    D.2.1.1.2Name of the Marketing Authorisation holderB. BRAUN MEDICAL
    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 nameMETRONIDAZOLE B BRAUN 0,5 %, solution pour perfusion
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 LEVOFLOXACINE ARROW 5 mg/ml, solution pour perfusion en poche
    D.2.1.1.2Name of the Marketing Authorisation holderARROW GENERIQUES
    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 name: LEVOFLOXACINE ARROW 5 mg/ml, solution pour perfusion en poche
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    Patients with preoperative biliary stent treated by pancreaticoduodenectomy
    Patients avec stent biliaire préopératoire traités par duodénopancréatectomie
    E.1.1.1Medical condition in easily understood language
    Patients with preoperative biliary stent treated by pancreaticoduodenectomy
    Patients avec stent biliaire préopératoire traités par duodénopancréatectomie
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10073866
    E.1.2Term Tumor of hepatopancreatic ampulla
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare 2 broad-spectrum antibiotic (Piperacillin / Tazobactam) treatment modalities to demonstrate the superiority of a 5-day post-operative antibiotic therapy to antibiotic prophylaxis on the occurrence of surgical site infections (SSI)
    Comparer 2 modalités de traitement par antibiotique à large spectre (Pipéracilline / Tazobactam) afin de démontrer la supériorité d'une antibiothérapie postopératoire de 5 jours par rapport à une antibioprophylaxie sur la survenue d'infections du site opératoire (ISO).
    E.2.2Secondary objectives of the trial
    The secondary objectives, with complications/morbidity assessed at 90 days, are as follows:
    • Evaluation of the overall morbidity associated with the different treatment modes by recording surgical complications
    • Evaluation of antibiotic resistance profiles and their impact on post-operative complications
    • Assessment of the pathogenicity of bacteriological and fungal co-contamination
    • Evaluation of the impact of complications after bile drainage and neoadjuvant treatment on the bacteriological and fungal profile of biliculture
    • Cost effectiveness analysis
    Les objectifs secondaires, avec des complications/morbidité évaluées à 90 jours, sont les suivants :
    - Évaluation de la morbidité globale associée aux différents modes de traitement par l'enregistrement des complications chirurgicales.
    - Evaluation des profils de résistance aux antibiotiques et de leur impact sur les complications post-opératoires.
    - Évaluation de la pathogénicité des co-contaminations bactériologiques et fongiques.
    - Évaluation de l'impact des complications après drainage biliaire et traitement néoadjuvant sur le profil bactériologique et fongique de la biliculture.
    - Analyse coût-efficacité
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Planned pancreaticoduodenectomy for periampullary neoplasms
    • Endoscopic or radiological pre-operative biliary drainage
    • Age ≥ 18 years old
    • Patient able to comply with the study protocol, in the investigator’s judgment
    • Patient affiliated with, or beneficiary of a social security (health insurance) category
    • Person of full age having read and understood the information letter and signed the consent form
    • Women of childbearing potential with effective contraception (Cf. CTFG) (oestro-progestatives or intra-uterine device or tubal ligation) since 1 month and an negative blood pregnancy test by -HCG at inclusion, during the duration of the study.
    • Women surgically sterile (absence of ovaries and/or uterus)
    • Postmenopausal women : confirmation diagnostic (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)

    - Pancréaticoduodénectomie prévue pour des néoplasmes périampullaires
    - Drainage biliaire préopératoire endoscopique ou radiologique.
    - Âge ≥ 18 ans
    - Patient capable de se conformer au protocole de l'étude, selon le jugement de l'investigateur.
    - Patient affilié à, ou bénéficiaire d'une catégorie de sécurité sociale (assurance maladie).
    - Personne majeure ayant lu et compris la lettre d'information et signé le formulaire de consentement.
    - Femmes en âge de procréer ayant une contraception efficace (Cf. CTFG) (oestro-progestatifs ou dispositif intra-utérin ou ligature des trompes) depuis 1 mois et un test de grossesse sanguin négatif par -HCG à l'inclusion, pendant la durée de l'étude.
    - Femmes chirurgicalement stériles (absence d'ovaires et/ou d'utérus).
    - Femmes ménopausées : diagnostic de confirmation (aménorrhée non médicalement provoquée pendant au moins 12 mois avant la visite d'inclusion).

    E.4Principal exclusion criteria
    • Contraindication to PIPERACILLIN/TAZOBACTAM PANPHARMA 4g / 500mg powder for solution for injection and LEVOFLOXACINE ARROW 5mg/ml solution for infusion in bag + METRONIDAZOLE B BRAUN 0,5%, solution for infusion*
    • Others pancreatic resection
    • Absence of preoperative biliary drainage
    • Surgical or anaesthesiological contra-indications:
    • non-controlled congestive heart failure – non-treated angina – recent myocardial infarction (in the previous year) – non-controlled AHT (SBP >160 mm or DBP > 100 mm, despite optimal drug treatment), long QT
    • major non-controlled infection
    • severe liver failure
    • Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
    • Any significant disease, which, in the investigator’s opinion, would exclude the patient from the study
    • Pregnant or parturient or breastfeeding woman or absence of contraceptionn
    • Person deprived of liberty by administrative or judicial decision or person placed under judicial protection, under guardianship or supervision
    • Simultaneous participation in another interventional research with the same primary endpoint.
    - Contre-indication à la PIPERACILLINE/TAZOBACTAM PANPHARMA 4g / 500mg poudre pour solution injectable et LEVOFLOXACINE ARROW 5mg/ml solution pour perfusion en poche + METRONIDAZOLE B BRAUN 0,5%, solution pour perfusion*.
    - Autres résections pancréatiques
    - Absence de drainage biliaire préopératoire
    - Contre-indications chirurgicales ou anesthésiologiques :
    - insuffisance cardiaque congestive non contrôlée - angor non traité - infarctus du myocarde récent (au cours de l'année précédente) - HTA non contrôlée (TAS >160 mm ou TAD > 100 mm, malgré un traitement médicamenteux optimal), QT long
    - infection majeure non contrôlée
    - insuffisance hépatique grave
    - Conditions médicales, géographiques, sociologiques, psychologiques ou juridiques qui ne permettraient pas au patient de mener à bien l'étude ou de signer un consentement éclairé
    - Toute maladie significative qui, de l'avis de l'investigateur, exclurait le patient de l'étude
    - Femme enceinte, parturiente ou allaitante ou absence de contraceptionn
    - Personne privée de liberté par décision administrative ou judiciaire ou personne placée sous protection judiciaire, sous tutelle ou sous curatelle.
    - Participation simultanée à une autre recherche interventionnelle ayant le même critère d'évaluation primaire.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the presence of organ/space SSI determined according to the Centers for Disease Control and Prevention’s national nosocomial infections surveillance system. Organ/space SSIs included postoperative pancreatic fistula (POPF) and bile leakage, with positive culture results.
    Le critère d'évaluation principal est la présence d'une ISO dans un organe ou un espace, déterminée selon le système national de surveillance des infections nosocomiales des Centers for Disease Control and Prevention. Les ISO d'organe/espace comprennent la fistule pancréatique postopératoire (FOP) et la fuite de bile, avec des résultats de culture positifs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    during the 5 post-operative days
    Pendant les 5 jours post-opératoires
    E.5.2Secondary end point(s)
    The study’s secondary criteria are as follows:
    • Infectious complications at post-operative day 90
    Overall postsurgical morbidity, graded according to the Dindo/Clavien classification and CCI score at post operative day 90
    Specific morbidity due to pancreatic fistula, graded according to the International Study Group of Pancreatic Fistula (ISGPF) criteria
    Readmission rates at post-operative day 90
    Duration of hospitalization
    • Correlation between post-operative bacteriological samples and intraoperative bile samples
    • Bacteriological resistance profiles
    Incidence of fungal contamination
    • Correlation between bacteriological and fungal contaminations
    • Incremental cost per infectious complications avoided
    Les critères secondaires de l'étude sont les suivants :
    - Complications infectieuses au jour 90 postopératoire
    Morbidité post-chirurgicale globale, classée selon la classification de Dindo/Clavien et le score CCI au 90e jour postopératoire.
    Morbidité spécifique due à la fistule pancréatique, évaluée selon les critères de l'International Study Group of Pancreatic Fistula (ISGPF).
    Taux de réadmission au 90e jour postopératoire
    Durée de l'hospitalisation
    - Corrélation entre les échantillons bactériologiques postopératoires et les échantillons biliaires peropératoires
    - Profils de résistance bactériologique
    Incidence de la contamination fongique
    - Corrélation entre les contaminations bactériologiques et fongiques
    - Coût différentiel par complication infectieuse évitée
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the 5 post-operative days
    Pendant les 5 jours post-opératoires
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 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
    Prophylaxie versus 5 jours de traitement
    Prophylaxis versus 5 days of treatment
    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 concerned26
    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
    DVDP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    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: 226
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state326
    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)
    none
    aucun
    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 Decision2023-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-03
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 02 22:43:52 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA