Anti-infective external coating of central venous catheters: A randomized, noninferiority trial comparing 5-fluorouracil with chlorhexidine/silver sulfadiazine in preventing catheter colonization

Critical Care Medicine

Volumn 38, Issue 11, 2010, Pages 2095-2102

  Walz, J Matthias ^a   Avelar, Rui L ^b   Longtine, Karen J ^a   Carter, Kent L ^e   Mermel, Leonard A ^c,d   Heard, Stephen O ^a  

^a UMASS MEMORIAL MEDICAL CENTER   (United States)

^b Angiotech Pharmaceuticals Inc   (Canada)

^c BROWN UNIVERSITY   (United States)

^d RHODE ISLAND HOSPITAL   (United States)

^e NONE

Author keywords

5 fluorouracil; catheter related infection; central venous catheterization; intensive care; microbial colony forming units assay; randomized controlled trial

Indexed keywords

CHLORHEXIDINE; FLUOROURACIL; SULFADIAZINE SILVER; ANTIMETABOLITE; TOPICAL ANTIINFECTIVE AGENT;

ADULT; ANEMIA; ARTICLE; BLINDNESS; BLOODSTREAM INFECTION; CANDIDA; CATHETER INFECTION; CENTRAL VENOUS CATHETER; CLINICAL TRIAL; COLONY FORMING UNIT; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CRITICALLY ILL PATIENT; CULTURE MEDIUM; DRUG FATALITY; DRUG SAFETY; FEMALE; GRAM NEGATIVE BACTERIUM; GRAM POSITIVE BACTERIUM; HEART ATRIUM FIBRILLATION; HUMAN; INCIDENCE; INTENSIVE CARE UNIT; INTRAVENOUS CATHETER; MAJOR CLINICAL STUDY; MALE; MEDICAL CARE; MICROBIAL COLONIZATION; MICROBIAL GROWTH; MULTICENTER STUDY; NAUSEA; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; UNITED STATES; VEIN CATHETERIZATION; ANTIBIOTIC PROPHYLAXIS; BACTERIAL COUNT; CENTRAL VENOUS CATHETERIZATION; COMPARATIVE STUDY; INDWELLING CATHETER; INSTRUMENTATION; INTENSIVE CARE; METHODOLOGY; MICROBIOLOGY; MIDDLE AGED; PROSPECTIVE STUDY; TREATMENT OUTCOME;

ANTI-INFECTIVE AGENTS, LOCAL; ANTIBIOTIC PROPHYLAXIS; ANTIMETABOLITES; CATHETER-RELATED INFECTIONS; CATHETERIZATION, CENTRAL VENOUS; CATHETERS, INDWELLING; CHLORHEXIDINE; COLONY COUNT, MICROBIAL; FEMALE; FLUOROURACIL; HUMANS; INTENSIVE CARE; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; SILVER SULFADIAZINE; SINGLE-BLIND METHOD; TREATMENT OUTCOME;

EID: 78049417599     PISSN: 00903493     EISSN: 15300293     Source Type: Journal    
DOI: 10.1097/CCM.0b013e3181f265ba     Document Type: Article

References (40)

1. Mermel LA: Prevention of intravascular catheter-related infections. Ann Intern Med 2000;132:391-402.
2. Erratum: Mermel LA: Correction: Catheter-related bloodstream infections. Ann Intern Med 2000;133:395
3. Coello R, Charlett A, Ward V, et al: Devicerelated sources of bacteraemia in English hospitals-Opportunities for the prevention of hospital-acquired bacteraemia. J Hosp Infect 2003;53:46-57
4. van der Kooi TI, de Boer AS, Manniën J, et al: Incidence and risk factors of device-associated infections and associated mortality at the intensive care in the Dutch surveillance system. Intensive Care Med 2007;33:271-278
5. Wisplinghoff H, Bischoff T, Tallent SM, et al: Nosocomial bloodstream infections in US hospitals: Analysis of 24, 179 cases from a prospective nationwide surveillance study. Clin Infect Dis 2004;39:309-317
6. Raad I, Hanna H, Maki D: Intravascular catheter-related infections: Advances in diagnosis, prevention, and management. Lancet Infect Dis 2007;7:645-657
7. Marschall J, Mermel LA, Classen D, et al: Strategies to prevent central line-associated bloodstream infections in acute care hospitals. Infect Control Hosp Epidemiol 2008;29(Suppl 1):S22-S30
8. Sampath LA, Tambe SM, Modak SM: In vitro and in vivo efficacy of catheters impregnated with antiseptics or antibiotics: Evaluation of the risk of bacterial resistance to the antimicrobials in the catheters. Infect Control Hosp Epidemiol 2001;22:640-646
9. Casey AL, Mermel LA, Nightingale P, et al: Antimicrobial central venous catheters in adults: A systematic review and metaanalyses. Lancet Infect Dis 2008;8:763-776
10. Walz JM, Fontecchio S, Heard SO: Use of catheters impregnated with minocycline and rifampin and the risk of fungemia. Crit Care Med 2001;29:A109
11. Darouiche RO, Berger DH, Khardori N, et al: Comparison of antimicrobial impregnation with tunneling of long-term central venous catheters: A randomized controlled trial. Ann Surg 2005;242:193-200
12. Fraenkel D, Rickard C, Thomas P, et al: A prospective, randomized trial of rifampicin-minocycline-coated and silver-platinum-carbon-impregnated central venous catheters. Crit Care Med 2006;34:668-675
13. Hanna H, Bahna P, Reitzel R, et al: Comparative in vitro efficacies and antimicrobial durabilities of novel antimicrobial central venous catheters. Antimicrob Agents Chemother 2006;50:3283-3288
14. Landsdown AB, Williams A: Bacterial resistance to silver in wound care and medical devices. J Wound Care 2007;16:15-19
15. Batra R, Cooper BS, Whiteley C, et al: Efficacy and limitation of a chlorhexidine-based decolonization strategy in preventing transmission of methicillin-resistant Staphylococcus aureus in an intensive care unit. Clin Infect Dis 2010;50:210-217
16. Chuanchuen R, Pathanasophon P, Khemtong S, et al: Susceptibilities to antimicrobials and disinfectants in Salmonella isolates obtained from poultry and swine in Thailand. J Vet Med Sci 2008;70:595-601
17. Brooks SE, Walczak MA, Hameed R, et al: Chlorhexidine resistance in antibioticresistant bacteria isolated from the surfaces of dispensers of soap containing chlorhexidine. Infect Control Hosp Epidemiol 2002;23:692-695
18. Jee R, Nel L, Gnanakumaran G, et al: Four cases of anaphylaxis to chlorhexidine impregnated central venous catheters: A case cluster or the tip of the iceberg? Br J Anaesth 2009;103:614-615
19. Cohen SS, Flaks JG, Barner HD, et al: The mode of action of 5-fluorouracil and its derivatives. Proc Natl Acad Sci U S A 1958;44:1004-1012
20. Kesavan C, Joyee AG: 5-fluorouracil altered morphology and inhibited growth of Candida albicans. J Clin Microbiol 2005;43:6215-6216
21. Bean B, Tomasz A: Inhibitory effects and metabolism of 5-fluoropyrimidine derivatives in pneumococcus. J Bacteriol 1971;106:412-420
22. Andoh T, Chargaff E: Formation and fate of abnormal ribosomes of E. coli cells treated with 5-fluorouracil. Proc Natl Acad Sci U S A 1965;54:1181-1119
23. Avelar R, Jonker A: Catheter-based drug device combination products: The anti-infective 5-fluorouracil-coated central venous catheter (5-FU CVC). In: Drug device combination products: Delivery technologies and applications. Lewis A (Ed). Cambridge, UK, Woodhead Publishing, 2010, pp 93-116
24. Maki DG, Weise CE, Sarafin HW: A semiquantitative culture method for identifying intravenous-catheter-related infection. N Engl J Med 1977;296:1305-1309
25. Clinical and laboratory standards institute methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically. Seventh Edition. Wayne, PA, Clinical and Laboratory Standards Institute, 2006
26. Burke K: Combating phlebitis: A peripheral cannula grading scale. Nurs Times 2000;96:38-39
27. Blackwelder WC: 'Proving the null hypothesis' in clinical trials. Control Clin Trials 1982;3:345-353
28. Rijnders BJ, Van Wijngaerden E, Peetermans WE: Catheter-tip colonization as a surrogate end point in clinical studies on catheter-related bloodstream infection: How strong is the evidence? Clin Infect Dis 2002;35:1053-1058
29. Ramritu P, Halton K, Collignon P, et al: A systematic review comparing the relative effectiveness of antimicrobial-coated catheters in intensive care units. Am J Infect Control 2008;36:104-117
30. Rupp ME, Lisco SJ, Lipsett PA, et al: Effect of a second-generation venous catheter impregnated with chlorhexidine and silver sulfadiazine on central catheter-related infections: A randomized, controlled trial. Ann Intern Med 2005;143:70-80
31. Halton K, Graves N: Economic evaluation and catheter-related bloodstream infections. Emerg Infect Dis 2007;13:815-823
32. Pronovost P, Needham D, Berenholtz S, et al: An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med 2006;355:2725-2732
33. Yilmaz G, Caylan R, Aydin K, et al: Effect of education on the rate of and the understanding of risk factors for intravascular catheterrelated infections. Infect Control Hosp Epidemiol 2007;28:689-694
34. Pronovost PJ, Goeschel CA, Wachter RM: The wisdom and justice of not paying for 'preventable complications.' JAMA 2008;299:2197-2199
35. James GA, Fisher S, Rosebrough SF: Prevention of Staphylococcal aureus biofilm in vitro using 5-FU-coated central venous catheters. ICAAC 48th Annual Meeting, October 25-28, 2008, Washington, DC. Presentation #C-190
36. Rosebrough SF, Chamberlain A: Local tissue and intravascular safety evaluation of a 5-fluorouracil coated central venous catheter in a goat model. ICAAC 48th Annual Meeting, October 25-28, 2008, Washington, DC. Presentation #K-33989
37. Sherertz RJ, Heard SO, Raad II: Diagnosis of triple lumen catheter infection: Comparison of roll plate, sonication, and flushing methodologies. J Clin Microbiol 1997;35:641-646
38. Bouza E, Alvarado N, Alcala L, et al: A prospective, randomized, and comparative study of 3 different methods for the diagnosis of intravascular catheter colonization. Clin Infect Dis 2005;40:1096-1100
39. Slobbe L, el Barzouhi A, Boersma E, et al: Comparison of the roll plate method to the sonication method to diagnose catheter colonization and bacteremia in patients with long-term tunneled catheters: A randomized prospective study. J Clin Microbiol 2009;47:885-888
40. Schmitt SK, Knapp C, Hall GS, et al: Impact of chlorhexidine-silver sulfadiazine-impregnated central venous catheters on in vitro quantitation of catheter-associated bacteria. J Clin Microbiol 1996;34:508-511