Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT00515151
Status:
COMPLETED
Last Update Posted:
2007-08-13
First Post:
2007-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Catheter-Associated Infection With the Skin Disinfectant Octenidine Dihydrochloride
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055499', 'term': 'Catheter-Related Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C034213', 'term': 'octenidine'}, {'id': 'D000433', 'term': '1-Propanol'}, {'id': 'D019840', 'term': '2-Propanol'}, {'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-08-10', 'studyFirstSubmitDate': '2007-08-10', 'studyFirstSubmitQcDate': '2007-08-10', 'lastUpdatePostDateStruct': {'date': '2007-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin colonisation in cfu/cm2 at the insertion site; Colonisation of the CVC-tip, positivity by definition of number cfu/5cm > 15 (Maki-method); Incidence of catheter-associated bloodstream infection', 'timeFrame': 'For the duration of catheter placement plus 2 days'}], 'secondaryOutcomes': [{'measure': 'Comparison of therapy regimens regarding side effects and complications', 'timeFrame': 'For the duration of catheter placement plus 30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bloodstream Infection', 'Bacteremia', 'Central Venous Catheter', 'Alcohol', 'Disinfection', 'Octenidine Dihydrochloride'], 'conditions': ['Catheterization, Central Venous', 'Catheter-Associated Infections', 'Bacterial Infections', 'Bacteremia']}, 'referencesModule': {'references': [{'pmid': '10691590', 'type': 'BACKGROUND', 'citation': 'Mermel LA. Prevention of intravascular catheter-related infections. Ann Intern Med. 2000 Mar 7;132(5):391-402. doi: 10.7326/0003-4819-132-5-200003070-00009.'}, {'pmid': '15824981', 'type': 'BACKGROUND', 'citation': 'Dettenkofer M, Wenzler-Rottele S, Babikir R, Bertz H, Ebner W, Meyer E, Ruden H, Gastmeier P, Daschner FD; Hospital Infection Surveillance System for Patients with Hematologic/Oncologic Malignancies Study Group. Surveillance of nosocomial sepsis and pneumonia in patients with a bone marrow or peripheral blood stem cell transplant: a multicenter project. Clin Infect Dis. 2005 Apr 1;40(7):926-31. doi: 10.1086/428046. Epub 2005 Mar 4.'}, {'pmid': '9525387', 'type': 'BACKGROUND', 'citation': 'Raad I. Intravascular-catheter-related infections. Lancet. 1998 Mar 21;351(9106):893-8. doi: 10.1016/S0140-6736(97)10006-X. No abstract available.'}, {'pmid': '14647886', 'type': 'BACKGROUND', 'citation': 'Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with noncuffed short-term central venous catheters. Intensive Care Med. 2004 Jan;30(1):62-7. doi: 10.1007/s00134-003-2045-z. Epub 2003 Nov 26.'}, {'pmid': '12517020', 'type': 'BACKGROUND', 'citation': "O'Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Infect Control Hosp Epidemiol. 2002 Dec;23(12):759-69. doi: 10.1086/502007."}, {'pmid': '12044127', 'type': 'BACKGROUND', 'citation': 'Chaiyakunapruk N, Veenstra DL, Lipsky BA, Saint S. Chlorhexidine compared with povidone-iodine solution for vascular catheter-site care: a meta-analysis. Ann Intern Med. 2002 Jun 4;136(11):792-801. doi: 10.7326/0003-4819-136-11-200206040-00007.'}, {'pmid': '3909955', 'type': 'BACKGROUND', 'citation': 'Sedlock DM, Bailey DM. Microbicidal activity of octenidine hydrochloride, a new alkanediylbis[pyridine] germicidal agent. Antimicrob Agents Chemother. 1985 Dec;28(6):786-90. doi: 10.1128/AAC.28.6.786.'}, {'pmid': '12183146', 'type': 'BACKGROUND', 'citation': 'Buhrer C, Bahr S, Siebert J, Wettstein R, Geffers C, Obladen M. Use of 2% 2-phenoxyethanol and 0.1% octenidine as antiseptic in premature newborn infants of 23-26 weeks gestation. J Hosp Infect. 2002 Aug;51(4):305-7. doi: 10.1053/jhin.2002.1249.'}, {'pmid': '16156327', 'type': 'BACKGROUND', 'citation': 'Tietz A, Frei R, Dangel M, Bolliger D, Passweg JR, Gratwohl A, Widmer AE. Octenidine hydrochloride for the care of central venous catheter insertion sites in severely immunocompromised patients. Infect Control Hosp Epidemiol. 2005 Aug;26(8):703-7. doi: 10.1086/502606.'}, {'pmid': '12382087', 'type': 'BACKGROUND', 'citation': 'Dettenkofer M, Jonas D, Wiechmann C, Rossner R, Frank U, Zentner J, Daschner FD. Effect of skin disinfection with octenidine dihydrochloride on insertion site colonization of intravascular catheters. Infection. 2002 Oct;30(5):282-5. doi: 10.1007/s15010-002-2182-2.'}, {'pmid': '15791507', 'type': 'BACKGROUND', 'citation': 'Bouza E, Alvarado N, Alcala L, Sanchez-Conde M, Perez MJ, Munoz P, Martin-Rabadan P, Rodriguez-Creixems M. A prospective, randomized, and comparative study of 3 different methods for the diagnosis of intravascular catheter colonization. Clin Infect Dis. 2005 Apr 15;40(8):1096-100. doi: 10.1086/428576. Epub 2005 Mar 17.'}, {'pmid': '10866442', 'type': 'BACKGROUND', 'citation': 'Eggimann P, Harbarth S, Constantin MN, Touveneau S, Chevrolet JC, Pittet D. Impact of a prevention strategy targeted at vascular-access care on incidence of infections acquired in intensive care. Lancet. 2000 May 27;355(9218):1864-8. doi: 10.1016/S0140-6736(00)02291-1.'}, {'pmid': '1677698', 'type': 'BACKGROUND', 'citation': 'Maki DG, Ringer M, Alvarado CJ. Prospective randomised trial of povidone-iodine, alcohol, and chlorhexidine for prevention of infection associated with central venous and arterial catheters. Lancet. 1991 Aug 10;338(8763):339-43. doi: 10.1016/0140-6736(91)90479-9.'}, {'pmid': '19686276', 'type': 'DERIVED', 'citation': 'Dettenkofer M, Wilson C, Gratwohl A, Schmoor C, Bertz H, Frei R, Heim D, Luft D, Schulz S, Widmer AF. Skin disinfection with octenidine dihydrochloride for central venous catheter site care: a double-blind, randomized, controlled trial. Clin Microbiol Infect. 2010 Jun;16(6):600-6. doi: 10.1111/j.1469-0691.2009.02917.x. Epub 2009 Aug 17.'}]}, 'descriptionModule': {'briefSummary': 'Health-care-acquired infections are of tremendous importance for patients, especially catheter-associated infections. More than 40% of all bloodstream infections are associated with central venous catheters (CVC; catheters which are inserted into a large vein near the heart). Of all patients that acquire such an infection 1% to 5% die as a result from it. The insertion site is the main source of contamination and infection. In general, bacteria of the skin are the cause of infection, especially in short-term CVCs (10-14 days). Therefore it is necessary to efficiently disinfect the skin for the preparation and care of CVC insertion sites. Several substances are used for disinfection. Alcohol-based disinfectants are mainly used in Central Europe, other preparations contain povidine-iodine or chlorhexidine. Alcoholic disinfectants have a rapid initial effect, chlorhexidine shows an additional remanent (longer lasting) effect. A further substance, octenidine dihydrochloride, also demonstrated a remanent effect in a pilot study with neurosurgical patients. The purpose of our study is to compare an alcohol-based disinfectant containing octenidine dihydrochloride with a pure alcoholic disinfectant regarding efficacy and tolerability in patients receiving a CVC for a minimum of 5 days.', 'detailedDescription': 'Catheter-associated infections are one of the most eminent healthcare acquired infections. More than 40% of all bloodstream infections are associated with a central venous catheter (CVC)and between 1% and 5% of the affected patients die as a direct consequence of this infection. The most important microorganisms are gram-positive cocci (S. aureus, S. epidermidis). In intensive care units gram-negative microorganisms such as pseudomonas, acinetobacter and candida spp. are more frequent. The insertion site is the main source of contamination and infection in short-term CVCs (10-14 days. In this case the infection is caused by migration of microorganisms along the outside of the catheter. Contamination of the hub due to frequent manipulation is usually the source of infection in long-term CVCs. In this case the infection occurs intraluminally. An effective skin disinfection is the main measure of prevention before insertion of a CVC. The aim of this measure is the elimination of transient and the reduction of resident microorganisms around the insertion site. To achieve this, disinfectants on the basis of alcohol, povidone-iodine or chlorhexidine are applied. Alcohol-based disinfectants are preferred in Central Europe because of their rapid initial effect and broad microbiological spectrum. Chlorhexidine and povidone-Iodine in contrast to alcoholic disinfectants have a remanent effect which reduces regrowth of microorganisms beyond the immediate initial effect. To which extent remanent substances reduce colonization of the CVC extraluminally or the CVC-tip is still being disputed. In an earlier clinical trial a residual or remanent effect of 0.1% octenidine combined with propanol in microbial skin decontamination over a 24h period was shown in neurosurgical patients receiving a central line (CVC or peripherally inserted central catheter). The objective of this study is therefore to evaluate further the preventive impact and tolerability of a commercially available, alcohol-based antiseptic solution containing octenidine for the preparation and care of CVC insertion sites in a clinical setting in comparison with the results given by an alcoholic solution alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>18 years\n* Medical indication for CVC with a planned duration of minimum 5 days\n* Patient´s (or relative´s if applicable) written informed consent\n\nExclusion Criteria:\n\n* Known sensitisation against the proposed antiseptics\n* Tunneled or implanted CVCs (e.g. Hickman Catheter)\n* Administration of antimicrobial drugs for therapy (not prophylaxis) less than one week prior to catheterization\n* Pre-existing bloodstream infection (i.e., fever and/or other signs of infection)\n* Positive blood culture\n* Terminal patients with limited therapy options\n* Patients with burns\n* Patients participating in a clinical trial on other antiseptics within a period of four weeks prior to inclusion date\n* Patients with missing written consent'}, 'identificationModule': {'nctId': 'NCT00515151', 'briefTitle': 'Prevention of Catheter-Associated Infection With the Skin Disinfectant Octenidine Dihydrochloride', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Freiburg'}, 'officialTitle': 'Skin Disinfection With Octenidine Dihydrochloride for the Prevention of Catheter-Associated Infections - A Double-Blind, Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'NEO-0102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oct/Alc', 'interventionNames': ['Drug: 0.1% Octenidine with 30% 1-propanol and 45% 2-propanol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alc', 'interventionNames': ['Drug: 74% Ethanol with 10% 2-propanol']}], 'interventions': [{'name': '0.1% Octenidine with 30% 1-propanol and 45% 2-propanol', 'type': 'DRUG', 'otherNames': ['Octeniderm', 'Neo-Kodan'], 'description': 'Before insertion of the catheter, the entry site was disinfected with the assigned solution over an area of \\>200 cm² for at least one minute. The assigned solution was then applied for care of the entry site during the change of dressings, usually every 2 to 3 days.', 'armGroupLabels': ['Oct/Alc']}, {'name': '74% Ethanol with 10% 2-propanol', 'type': 'DRUG', 'otherNames': ['Softasept'], 'description': 'Before insertion of the catheter, the entry site was disinfected with the assigned solution over an area of \\>200 cm² for at least one minute. The assigned solution was then applied for care of the entry site during the change of dressings, usually every 2 to 3 days.', 'armGroupLabels': ['Alc']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Institute of Environmental Medicine and Hospital Epidemiology University Medical Center Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Basel', 'country': 'Switzerland', 'facility': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Markus Dettenkofer, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Environmental Medicine and Hospital Epidemiology University Medical Center Freiburg, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Freiburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}]}}}