Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-28 @ 4:36 AM
Study NCT ID:
NCT01629550
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2012-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Randomized Controlled Multicenter Trial of 4 Antiseptic Strategies for Prevention of Catheter Infection in Intensive Care Unit for Adults Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 2400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'lastUpdateSubmitDate': '2016-10-10', 'studyFirstSubmitDate': '2012-06-20', 'studyFirstSubmitQcDate': '2012-06-25', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major catheter related infection'}], 'secondaryOutcomes': [{'measure': 'Catheter colonization'}, {'measure': 'Catheter related bacteremia'}, {'measure': 'Colonization insertion site'}, {'measure': 'Prolongation hospitalization due to catheter infection'}, {'measure': 'Mortality due to catheter infection'}, {'measure': 'Skin allergy and anaphylactic shock'}, {'measure': 'Costs'}]}, 'conditionsModule': {'conditions': ['Preventing Catheter Related Infection']}, 'referencesModule': {'references': [{'pmid': '36645531', 'type': 'DERIVED', 'citation': 'Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Valette X, Daubin C, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable model predicting the required catheter dwell time among mechanically ventilated critically ill patients in three randomized trials. Ann Intensive Care. 2023 Jan 16;13(1):5. doi: 10.1186/s13613-023-01099-9.'}, {'pmid': '35799302', 'type': 'DERIVED', 'citation': 'Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.'}, {'pmid': '32643100', 'type': 'DERIVED', 'citation': 'Buetti N, Ruckly S, Lucet JC, Bouadma L, Schwebel C, Mimoz O, Timsit JF. Ultrasound guidance and risk for intravascular catheter-related infections among peripheral arterial catheters: a post-hoc analysis of two large randomized-controlled trials. Ann Intensive Care. 2020 Jul 8;10(1):89. doi: 10.1186/s13613-020-00705-4.'}, {'pmid': '29799871', 'type': 'DERIVED', 'citation': 'Maunoury F, Farinetto C, Ruckly S, Guenezan J, Lucet JC, Lepape A, Pascal J, Souweine B, Mimoz O, Timsit JF. Cost-effectiveness analysis of chlorhexidine-alcohol versus povidone iodine-alcohol solution in the prevention of intravascular-catheter-related bloodstream infections in France. PLoS One. 2018 May 25;13(5):e0197747. doi: 10.1371/journal.pone.0197747. eCollection 2018.'}, {'pmid': '26388532', 'type': 'DERIVED', 'citation': 'Mimoz O, Lucet JC, Kerforne T, Pascal J, Souweine B, Goudet V, Mercat A, Bouadma L, Lasocki S, Alfandari S, Friggeri A, Wallet F, Allou N, Ruckly S, Balayn D, Lepape A, Timsit JF; CLEAN trial investigators. Skin antisepsis with chlorhexidine-alcohol versus povidone iodine-alcohol, with and without skin scrubbing, for prevention of intravascular-catheter-related infection (CLEAN): an open-label, multicentre, randomised, controlled, two-by-two factorial trial. Lancet. 2015 Nov 21;386(10008):2069-2077. doi: 10.1016/S0140-6736(15)00244-5. Epub 2015 Sep 18.'}, {'pmid': '23782845', 'type': 'DERIVED', 'citation': 'Goudet V, Timsit JF, Lucet JC, Lepape A, Balayn D, Seguin S, Mimoz O. Comparison of four skin preparation strategies to prevent catheter-related infection in intensive care unit (CLEAN trial): a study protocol for a randomized controlled trial. Trials. 2013 Apr 27;14:114. doi: 10.1186/1745-6215-14-114.'}]}, 'descriptionModule': {'briefSummary': 'Catheter related infection is the third cause of nosocomial infection in ICUs. Most of them are avoidable and can be prevent by improving aseptic practices during catheter insertion and maintenance. Indeed, the main route of catheter contamination for short-term catheters is the insertion site. Consequently, the quality of skin disinfection is the most effective preventive measure to reduce the incidence of these infections.\n\nThis aim of the present study is to compare four strategies of skin disinfection to determine whether a 2% alcoholic solution of chlorhexidine acts better than 5% alcoholic povidone iodine in reducing catheter infection and to assess whether a detersion phase prior to disinfection reduces catheter colonization as compared with no detersion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 year-old\n* Expected duration of ICU stay ≥ 48 hours\n* Patient requiring the insertion of at least one arterial catheter and/or central venous catheter and/or catheter for hemodialysis.\n\nExclusion Criteria:\n\n* Patient with history of allergy to any of the antiseptic agent studied\n* Expected survival \\< 48 hours\n* Catheter inserted outside the ICU or in emergency without respect of preventive measures.\n* Use of antimicrobial impregnated catheters or antiseptic impregnated dressings.\n* Pregnant woman or breast-feeding mother'}, 'identificationModule': {'nctId': 'NCT01629550', 'acronym': 'CLEAN', 'briefTitle': 'Prospective Randomized Controlled Multicenter Trial of 4 Antiseptic Strategies for Prevention of Catheter Infection in Intensive Care Unit for Adults Patients', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'orgStudyIdInfo': {'id': 'CLEAN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PVI paint', 'description': '5% alcoholic povidone iodine paint', 'interventionNames': ['Procedure: skin disinfection prior catheter insertion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PVI scrub and paint', 'description': 'detersion with 4% povidone iodine scrub followed by 5% alcoholic povidone iodine paint', 'interventionNames': ['Procedure: skin disinfection prior catheter insertion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine paint', 'description': '2% alcoholic chlorhexidine paint', 'interventionNames': ['Procedure: skin disinfection prior catheter insertion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'chlorhexidine scrub and paint', 'description': 'Detersion with 4% chlorhexidine scrub followed 2% alcoholic chlorhexidine paint', 'interventionNames': ['Procedure: skin disinfection prior catheter insertion']}], 'interventions': [{'name': 'skin disinfection prior catheter insertion', 'type': 'PROCEDURE', 'armGroupLabels': ['Chlorhexidine paint', 'PVI paint', 'PVI scrub and paint', 'chlorhexidine scrub and paint']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'Angers University Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Estain University Hospital', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Bichat-Claude Bernard Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69465', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Lyon University Hospital', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Poitiers University Hospital', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}