Prevention of Catheter-Associated Infection With the Skin Disinfectant Octenidine Dihydrochloride

NCT00515151 | Completed Phase 4 DMC

• 1 other identifier: NEO-0102
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Catheterization, Central Venous; Catheter-Associated Infections; Bacterial Infections; Bacteremia

Keywords

Bloodstream Infection; Bacteremia; Central Venous Catheter; Alcohol; Disinfection; Octenidine Dihydrochloride

Outcome Measures

Primary Outcomes (1)

• 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

  For the duration of catheter placement plus 2 days

Secondary Outcomes (1)

• Comparison of therapy regimens regarding side effects and complications

  For the duration of catheter placement plus 30 days

Study Arms (2)

Oct/Alc

ACTIVE COMPARATOR

Drug: 0.1% Octenidine with 30% 1-propanol and 45% 2-propanol

Alc

ACTIVE COMPARATOR

Drug: 74% Ethanol with 10% 2-propanol

Interventions

0.1% Octenidine with 30% 1-propanol and 45% 2-propanol DRUG

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.

Also known as: Octeniderm, Neo-Kodan

Oct/Alc

74% Ethanol with 10% 2-propanol DRUG

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.

Also known as: Softasept

Alc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>18 years
• Medical indication for CVC with a planned duration of minimum 5 days
• Patient´s (or relative´s if applicable) written informed consent

You may not qualify if:

• Known sensitisation against the proposed antiseptics
• Tunneled or implanted CVCs (e.g. Hickman Catheter)
• Administration of antimicrobial drugs for therapy (not prophylaxis) less than one week prior to catheterization
• Pre-existing bloodstream infection (i.e., fever and/or other signs of infection)
• Positive blood culture
• Terminal patients with limited therapy options
• Patients with burns
• Patients with missing written consent

Sponsors & Collaborators

• University Hospital Freiburg: lead
• University Hospital, Basel, Switzerland: collaborator

Study Sites (2)

Institute of Environmental Medicine and Hospital Epidemiology University Medical Center Freiburg

Freiburg im Breisgau, Germany

Location

Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel

Basel, Switzerland

Location

Related Publications (14)

• 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: 10691590 BACKGROUND

• 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: 15824981 BACKGROUND

• 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: 9525387 BACKGROUND

• 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: 14647886 BACKGROUND

• 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: 12517020 BACKGROUND

• 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: 12044127 BACKGROUND

• 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: 3909955 BACKGROUND

• 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: 12183146 BACKGROUND

• 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: 16156327 BACKGROUND

• 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: 12382087 BACKGROUND

• 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: 15791507 BACKGROUND

• 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: 10866442 BACKGROUND

• 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: 1677698 BACKGROUND

• 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.

  PMID: 19686276 DERIVED

MeSH Terms

Conditions

Catheter-Related Infections; Bacterial Infections; Bacteremia; Sepsis

Interventions

octenidine; 1-Propanol; 2-Propanol; Ethanol

Condition Hierarchy (Ancestors)

Infections; Bacterial Infections and Mycoses; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanols; Alcohols; Organic Chemicals

Study Officials

• Markus Dettenkofer, Prof. MD

  Institute of Environmental Medicine and Hospital Epidemiology University Medical Center Freiburg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2007
• First Posted: August 13, 2007
• Study Start: May 1, 2002
• Study Completion: April 1, 2005
• Last Updated: August 13, 2007

Record last verified: 2007-08

Locations

DE (1); CH (1)