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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35511   clinical trials with a EudraCT protocol, of which   5839   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).
     
    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:2015-002559-84
    Sponsor's Protocol Code Number:PHRC-N-2014-FUTIER
    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:2015-08-05
    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 number2015-002559-84
    A.3Full title of the trial
    Intravenous versus combined oral and intravenous antimicrobial prophylaxis for the prevention of surgical site infection in elective colorectal surgery: A double-blinded multicenter prospective randomized controlled trial
    .
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    .
    Comparaison de deux stratégies antibiotiques pour diminuer le risque d’infection du site opératoire suite à une chirurgie colorectale non urgente
    A.3.2Name or abbreviated title of the trial where available
    COMBINE Study
    Etude COMBINE
    A.4.1Sponsor's protocol code numberPHRC-N-2014-FUTIER
    A.5.4Other Identifiers
    Name:.Number:.
    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 Clermont-Ferrand
    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 supportMinistère de la Santé (PHRC N 2014)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Clermont-Ferrand
    B.5.2Functional name of contact pointDélégation à la recherche clinique
    B.5.3 Address:
    B.5.3.1Street Address58 rue Montalemebert
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number00330473751195
    B.5.5Fax number00330473754730
    B.5.6E-mailplacarin@chu-clermontferrand.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 TIBERAL
    D.2.1.1.2Name of the Marketing Authorisation holderSERB
    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 Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNORNIDAZOLE
    D.3.9.1CAS number 16773-42-5
    D.3.9.4EV Substance CodeSUB09464MIG
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    .
    Antibioprophylaxie combinée en prévention des infections du site opératoire dans les chirurgies colorectales électives.
    E.1.1.1Medical condition in easily understood language
    .
    Antibioprophylaxie combinée en prévention des infections du site opératoire dans les chirurgies colorectales électives.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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
    .
    Evaluer si l’antibioprophylaxie combinée utilisant l'ornidazole orale (le jour avant la chirurgie) et une céphalosporine par voie intraveineuse (avant l'incision chirurgicale) par rapport à une antibioprophylaxie par une céphalosporine intraveineuse seule (pratique courante) en combinaison avec un placebo oral, a un effet sur l'incidence de des infections du site opératoire dans les 30 jours après la chirurgie colorectale élective.
    E.2.2Secondary objectives of the trial
    .
    - Déterminer la relation entre la stratégie d’antibioprophylaxie et l'incidence des différents types d’infections du site opératoire, ou ISO, (Infection superficielle de l'incision, infection profonde de l'incision et infection de l’abdomen dans les 30 jours après la chirurgie
    - Déterminer la tolérance de l'antibioprophylaxie (événements indésirables cliniques)
    - Décrire l'impact de l’ISO sur les complications postopératoires et sur la nécessité de réinterventions chirurgicales, sur la durée du séjour à l'hôpital et sur la mortalité postopératoire
    - Déterminer la relation entre l’ISO et le temps de mise en place de la chimiothérapie adjuvante
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    .
    Tous les patients adultes (âge ≥ 18 ans) devant subir une chirurgie colorectale élective par laparoscopie ou non
    E.4Principal exclusion criteria
    .
    - Chirurgie colorectale non élective
    - Procédure chirurgicale concomitante significative
    - Infection bactérienne au moment de la chirurgie ou thérapie antimicrobienne jusqu'à 2 semaines avant la chirurgie
    - Les maladies inflammatoires de l'intestin
    - L'obésité sévère (définie par un IMC > 35 kg/m2)
    - Antécédents connus d'hypersensibilité aux médicaments de l'étude (ornidazole, céfoxitine)
    - Déficience grave de la fonction rénale préopératoire
    - Les patients ayant une colonisation connue avec des bactéries digestives multirésistantes, en particulier gram négatif multirésistantes
    - Allergie au lactose
    - Les patientes enceintes
    - Le refus de participer ou de l'incapacité de fournir un consentement éclairé
    E.5 End points
    E.5.1Primary end point(s)
    .
    Survenue d'une infection du site opératoire ou ISO dans les 30 jours postopératoires. L’ISO sera classée comme superficielle, profonde et/ou une infection de l’abdomen selon les critères validés et définis par les centres pour le contrôle et la prévention des maladies (CDC).
    E.5.1.1Timepoint(s) of evaluation of this end point
    .
    30 jours postopératoire de la chirurgie colorectale élective
    E.5.2Secondary end point(s)
    - To determine the relationship between the antibiotic prophylaxis strategy and the incidence of individual types of SSI (superficial incision infection, deep incision infection and organ-space infection) within 30 days after surgery
    - To determine the safety of antibiotic prophylaxis (clinical adverse events)
    - To describe the effect of SSI on postoperative complications, surgical reintervention, duration of hospital stay and postoperative mortality
    - To determine the relationship between SSI and the time to introduction of adjuvant chemotherapy
    .
    E.5.2.1Timepoint(s) of evaluation of this end point
    .
    30 et 90 jours après la chirurgie colorectale élective
    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 No
    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 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 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) No
    E.8.2.2Placebo Yes
    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 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 concerned15
    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 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
    LVLS
    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 days0
    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: 620
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state920
    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)
    .
    La prise en charge des patients, lorsqu'ils ont terminé l'étude
    correspond à la prise en charge habituelle de tout patient ayant
    bénéficié de ce type de chirurgie.
    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 Decision2015-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-29
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA