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    Summary
    EudraCT Number:2020-000755-13
    Sponsor's Protocol Code Number:DACLEAN
    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:2020-02-25
    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 number2020-000755-13
    A.3Full title of the trial
    ESTIMATION OF THE INCIDENCE OF COLONIZATION OF PERIPHERAL VENOUS CATHETERS AFTER SKIN DISINFECTION WITH 0.5% SODIUM HYPOCHLORITE, PRECEDED OR NOT BY AN APPLICATION OF 70% ETHANOL: PILOT, MONOCENTRIC, RANDOMIZED, OPEN-LABEL STUDY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ESTIMATION OF THE INCIDENCE OF COLONIZATION OF PERIPHERAL VENOUS CATHETERS AFTER SKIN DISINFECTION WITH 0.5% SODIUM HYPOCHLORITE, PRECEDED OR NOT BY AN APPLICATION OF 70% ETHANOL: PILOT, MONOCENTRIC, RANDOMIZED, OPEN-LABEL STUDY
    A.3.2Name or abbreviated title of the trial where available
    DACLEAN
    A.4.1Sponsor's protocol code numberDACLEAN
    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 Poitiers
    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 Poitiers
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Poitiers
    B.5.2Functional name of contact pointFanny ABRIAT
    B.5.3 Address:
    B.5.3.1Street AddressDirection de la Recherche-CS90577
    B.5.3.2Town/ cityPOITIERS
    B.5.3.4CountryFrance
    B.5.4Telephone number33549443796
    B.5.5Fax number33549443058
    B.5.6E-mailfanny.abriat@chu-poitiers.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 DAKIN® - 0,5% Sodium Hypochlorite
    D.2.1.1.2Name of the Marketing Authorisation holderCOOPERATION PHARMACEUTIQUE FRANCAISE
    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 nameDAKIN®
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous 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 ALCOOL MODIFIE COOPER® - 70% Ethanol
    D.2.1.1.2Name of the Marketing Authorisation holderCOOPERATION PHARMACEUTIQUE FRANCAISE
    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 nameALCOOL MODIFIE COOPER®
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous 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
    Bacterial colonization of peripheral venous catheters
    E.1.1.1Medical condition in easily understood language
    Bacterial colonization of peripheral venous catheters
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10069718
    E.1.2Term Bacterial colonization
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Estimate the incidence of colonization of peripheral venous catheters after disinfection with a 0.5% sodium hypochlorite solution preceded or not by an application of a 70% ethanol solution.
    E.2.2Secondary objectives of the trial
    Assess the occurrence of local or systemic catheter-related infectious complications after disinfection with 0.5% sodium hypochlorite solution with or without application of 70% ethanol solution.

    Assess skin tolerance after disinfection with 0.5% sodium hypochlorite solution with or without application of 70% ethanol solution.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Impact of skin microbiome on infectious and non-infectious complications of peripheral intravenous catheter devices inserted after skin disinfection with DAKIN® alone or preceded by ethanol (KTBiome 2)
    Version n°1 du 19.02.2020
    Main Objective
    Determine the microbial signature to predict the colonization of a peripheral venous catheter, according to the skin disinfection protocol using 0.5% sodium hypochlorite versus 0.5% sodium hypochlorite preceded by ethanol.

    Secondary Objectives
    - Determine the ecological impact of sodium hypochlorite 0.5%.
    - Determine microbial associations to non-infectious adverse events
    o Phlebitis.
    o Catheter obstruction
    o Undesirable symptoms (pain, pruritus, ...)
    E.3Principal inclusion criteria
    - Adult patient (≥18 years old) requiring hospitalization in participating services
    - Having an indication for the placement of a peripheral venous catheter for an expected duration of at least 48 hours
    - Free subject, without guardianship or curatorship or subordination
    - A person affiliated to or benefiting from a social security scheme.
    - Having given free and informed consent
    E.4Principal exclusion criteria
    - Hypersensitivity to any of the constituents of Dakin® and/or Cooper® modified alcohol;
    - History of epilepsy,
    - Placement of a peripheral venous catheter in the emergency room that does not allow the usual rules of hygiene to be respected;
    - Difficult vascular access foreseeable (drug addict, obese, non-visible veins...);
    - Participation in another research protocol reducing the risk of catheter-related infection;
    - Patient having received an antibiotic treatment in the 15 days prior to inclusion in the study;
    - Patient who has already participated in the study;
    - Subjects not affiliated with a Social Security system.
    - Subjects benefiting from enhanced protection, namely persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection (guardianship and trusteeship) and finally patients in emergency situations.
    - Pregnant or breastfeeding women, women of child-bearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy...).
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of colonized catheters defined as the culture of the intravascular end of the catheter with at least 1000 colony-forming units per mL (CFU/mL)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The decision to remove the catheter is the responsibility of the patient's physician
    E.5.2Secondary end point(s)
    - Local infection, defined as colonization of the catheter if removed for suspicion of infection, or purulent discharge at the insertion site with a positive culture or no culture at the insertion site (a negative culture, in the absence of antibiotics, eliminates the case).
    - General infection, defined as colonization of the catheter in the presence of general signs of infection (fever > 38.5° or hypothermia < 36°, chills, hypotension with PAS < 90 mmHg) and total or partial regression of these signs within 48 hours after catheter removal.
    - catheter-related bacteremia/fungemia, defined as at least one positive peripheral blood culture within 48 hours of catheter removal, associated with general signs of infection (fever > 38.5° or hypothermia < 36°, chills, hypotension with PAS < 90 mmHg) and a catheter culture with the same microorganism (or pus at the site of catheter insertion), with no other infectious focus identified.
    - Incidence of a positive catheter culture regardless of the threshold and the microorganism under consideration.
    - Incidence of local skin reaction and its severity.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every day until the catheter is removed
    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 No
    E.6.4Safety Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Nothing
    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 No
    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
    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 months6
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state240
    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
    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 Decision2020-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-31
    P. End of Trial
    P.End of Trial StatusOngoing
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