The potential value of Clostridium difficile vaccine: An economic computer simulation model

Vaccine

Volumn 28, Issue 32, 2010, Pages 5245-5253

  Lee, Bruce Y ^a,b,c   Popovich, Michael J ^a,b,c   Tian, Ye ^a,b,c   Bailey, Rachel R ^a,b,c   Ufberg, Paul J ^a,b,c   Wiringa, Ann E ^a,b,c   Muder, Robert R ^b  

^a UNIVERSITY OF PITTSBURGH   (United States)

^b UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

Clostridium difficile; Computer simulation; Economics; Vaccine

Indexed keywords

BACTERIAL VACCINE; CLOSTRIDIUM DIFFICILE VACCINE; METRONIDAZOLE; UNCLASSIFIED DRUG; VANCOMYCIN;

AGED; ARTICLE; CLOSTRIDIUM DIFFICILE INFECTION; COMPUTER SIMULATION; COST EFFECTIVENESS ANALYSIS; DRUG COST; DRUG DOSE REDUCTION; DRUG EFFICACY; HIGH RISK PATIENT; HUMAN; INFECTION PREVENTION; MONTE CARLO METHOD; PRIORITY JOURNAL; RECURRENT DISEASE; SENSITIVITY ANALYSIS; COST BENEFIT ANALYSIS; ECONOMICS; ENTEROCOLITIS, PSEUDOMEMBRANOUS; PEPTOCLOSTRIDIUM DIFFICILE; RISK FACTOR; SECONDARY PREVENTION; STATISTICAL MODEL;

BACTERIAL VACCINES; CLOSTRIDIUM DIFFICILE; COMPUTER SIMULATION; COST-BENEFIT ANALYSIS; ENTEROCOLITIS, PSEUDOMEMBRANOUS; HUMANS; MODELS, ECONOMIC; MONTE CARLO METHOD; RECURRENCE; RISK FACTORS; SECONDARY PREVENTION;

EID: 77954953150     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2010.05.062     Document Type: Article

References (54)

1. Hull M.W., Beck P.L. Clostridium difficile-associated colitis. Can Fam Physician 2004, 50(November):1536-1540. 1543-5.
2. McFarland L.V. Update on the changing epidemiology of Clostridium difficile-associated disease. Nat Clin Pract Gastroenterol Hepatol 2008, 5(January (1)):40-48.
3. Gardiner D.F., Rosenberg T., Zaharatos J., Franco D., Ho D.D. A DNA vaccine targeting the receptor-binding domain of Clostridium difficile toxin A. Vaccine 2009, 27(June (27)):3598-3604.
4. Brun P., Scarpa M., Grillo A., Palu G., Mengoli C., Zecconi A., et al. Clostridium difficile TxAC314 and SLP-36kDa enhance the immune response toward a co-administered antigen. J Med Microbiol 2008, 57(June (Pt 6)):725-731.
5. Ni Eidhin D.B., O'Brien J.B., McCabe M.S., Athie-Morales V., Kelleher D.P. Active immunization of hamsters against Clostridium difficile infection using surface-layer protein. FEMS Immunol Med Microbiol 2008, 52(March (2)):207-218.
6. Pechine S., Janoir C., Boureau H., Gleizes A., Tsapis N., Hoys S., et al. Diminished intestinal colonization by Clostridium difficile and immune response in mice after mucosal immunization with surface proteins of Clostridium difficile. Vaccine 2007, 25(May (20)):3946-3954.
7. Ghose C., Kalsy A., Sheikh A., Rollenhagen J., John M., Young J., et al. Transcutaneous immunization with Clostridium difficile toxoid A induces systemic and mucosal immune responses and toxin A-neutralizing antibodies in mice. Infect Immun 2007, 75(June (6)):2826-2832.
8. Sougioultzis S., Kyne L., Drudy D., Keates S., Maroo S., Pothoulakis C., et al. Clostridium difficile toxoid vaccine in recurrent C. difficile-associated diarrhea. Gastroenterology 2005, 128(March (3)):764-770.
9. Aboudola S., Kotloff K.L., Kyne L., Warny M., Kelly E.C., Sougioultzis S., et al. Clostridium difficile vaccine and serum immunoglobulin G antibody response to toxin A. Infect Immun 2003, 71(March (3)):1608-1610.
10. Kelly C.P., LaMont J.T. Clostridium difficile - more difficult than ever. N Engl J Med 2008, 359(October (18)):1932-1940.
11. Warny M., Pepin J., Fang A., Killgore G., Thompson A., Brazier J., et al. Toxin production by an emerging strain of Clostridium difficile associated with outbreaks of severe disease in North America and Europe. Lancet 2005, 366(September (9491)):1079-1084.
12. Kotloff K.L., Wasserman S.S., Losonsky G.A., Thomas W., Nichols R., Edelman R., et al. Safety and immunogenicity of increasing doses of a Clostridium difficile toxoid vaccine administered to healthy adults. Infect Immun 2001, 69(February (2)):988-995.
13. Lee B.Y., Burke D.S. Constructing target product profiles (TPPs) to help vaccines overcome post-approval obstacles. Vaccine 2009, (September).
14. HCUP.net. Healthcare Cost and Utilization Project; 2007 [cited 2009 June 15]; Available from: http://www.ahrq.gov/HCUPnet/.
15. Sassi F. Calculating QALYs, comparing QALY and DALY calculations. Health Policy Plan 2006, 21(September (5)):402-408.
16. Hutubessy R., Chisholm D., Edejer T.T. Generalized cost-effectiveness analysis for national-level priority-setting in the health sector. Cost Eff Resour Alloc 2003, 1(December (1)):8.
17. Graves N., Halton K., Lairson D. Economics and preventing hospital-acquired infection: broadening the perspective. Infect Control Hosp Epidemiol 2007, 28(February (2)):178-184.
18. Murray C.J.L., Lopez A.D., Harvard School of Public Health, World Health Organization, World Bank The global burden of disease: a comprehensive assessment of mortality and disability from diseases, injuries and risk factors in 1990 and projected to 2020 1996, Published by the Harvard School of Public Health on behalf of the World Health Organization and the World Bank; Distributed by Harvard University Press, Cambridge, MA.
19. Ricciardi R., Rothenberger D.A., Madoff R.D., Baxter N.N. Increasing prevalence and severity of Clostridium difficile colitis in hospitalized patients in the United States. Arch Surg 2007, 142(July (7)):624-631. [discussion 31].
20. Cross A.S., Chen W.H., Levine M.M. A case for immunization against nosocomial infections. J Leukoc Biol 2008, 83(March (3)):483-488.
21. Holmgren J., Czerkinsky C. Mucosal immunity and vaccines. Nat Med 2005, 11(April (Suppl. 4)):S45-S53.
22. Neutra M.R., Kozlowski P.A. Mucosal vaccines: the promise and the challenge. Nat Rev Immunol 2006, 6(February (2)):148-158.
23. East Ohio Regional Hospital. Patient Price Information List; 2006 [cited 2009 August 5]; Available from: http://www.eastohioregionalhospital.com/pricelist.asp.
24. Red Book 2009 Pharmacy's fundamental reference 2009, Thomson Reuters, New York. 113 ed.
25. Schwengel D.A., McGready J., Berenholtz S.M., Kozlowski L.J., Nichols D.G., Yaster M. Peripherally inserted central catheters: a randomized, controlled, prospective trial in pediatric surgical patients. Anesth Analg 2004, 99(October (4)):1038-1043. [table of contents].
26. Kyne L., Warny M., Qamar A., Kelly C.P. Asymptomatic carriage of Clostridium difficile and serum levels of IgG antibody against toxin A. N Engl J Med 2000, 342(February (6)):390-397.
27. Johnson S., Clabots C.R., Linn F.V., Olson M.M., Peterson L.R., Gerding D.N. Nosocomial Clostridium difficile colonisation and disease. Lancet 1990, 336(July (8707)):97-100.
28. McFarland L.V., Mulligan M.E., Kwok R.Y., Stamm W.E. Nosocomial acquisition of Clostridium difficile infection. N Engl J Med 1989, 320(January (4)):204-210.
29. Shim J.K., Johnson S., Samore M.H., Bliss D.Z., Gerding D.N. Primary symptomless colonisation by Clostridium difficile and decreased risk of subsequent diarrhoea. Lancet 1998, 351(February (9103)):633-636.
30. Dallal R.M., Harbrecht B.G., Boujoukas A.J., Sirio C.A., Farkas L.M., Lee K.K., et al. Fulminant Clostridium difficile: an underappreciated and increasing cause of death and complications. Ann Surg 2002, 235(March (3)):363-372.
31. Dubberke E.R., Butler A.M., Reske K.A., Agniel D., Olsen M.A., D'Angelo G., et al. Attributable outcomes of endemic Clostridium difficile-associated disease in nonsurgical patients. Emerg Infect Dis 2008, 14(July (7)):1031-1038.
32. Miller M.A., Hyland M., Ofner-Agostini M., Gourdeau M., Ishak M. Morbidity, mortality, and healthcare burden of nosocomial Clostridium difficile-associated diarrhea in Canadian hospitals. Infect Control Hosp Epidemiol 2002, 23(March (3)):137-140.
33. Barbut F., Richard A., Hamadi K., Chomette V., Burghoffer B., Petit J.C. Epidemiology of recurrences or reinfections of Clostridium difficile-associated diarrhea. J Clin Microbiol 2000, 38(June (6)):2386-2388.
34. Barbut F., Gariazzo B., Bonne L., Lalande V., Burghoffer B., Luiuz R., et al. Clinical features of Clostridium difficile-associated infections and molecular characterization of strains: results of a retrospective study, 2000-2004. Infect Control Hosp Epidemiol 2007, 28(February (2)):131-139.
35. Fekety R., McFarland L.V., Surawicz C.M., Greenberg R.N., Elmer G.W., Mulligan M.E. Recurrent Clostridium difficile diarrhea: characteristics of and risk factors for patients enrolled in a prospective, randomized, double-blinded trial. Clin Infect Dis 1997, 24(March (3)):324-333.
36. Pepin J., Valiquette L., Alary M.E., Villemure P., Pelletier A., Forget K., et al. Clostridium difficile-associated diarrhea in a region of Quebec from 1991 to 2003: a changing pattern of disease severity. CMAJ 2004, 171(August (5)):466-472.
37. Rubin M.S., Bodenstein L.E., Kent K.C. Severe Clostridium difficile colitis. Dis Colon Rectum 1995, 38(April (4)):350-354.
38. Byrn J.C., Maun D.C., Gingold D.S., Baril D.T., Ozao J.J., Divino C.M. Predictors of mortality after colectomy for fulminant Clostridium difficile colitis. Arch Surg 2008, 143(February (2)):150-154. [discussion 5].
39. Hermsen J.L., Dobrescu C., Kudsk K.A. Clostridium difficile infection: a surgical disease in evolution. J Gastrointest Surg 2008, 12(September (9)):1512-1517.
40. Jobe B.A., Grasley A., Deveney K.E., Deveney C.W., Sheppard B.C. Clostridium difficile colitis: an increasing hospital-acquired illness. Am J Surg 1995, 169(May (5)):480-483.
41. Koss K., Clark M.A., Sanders D.S., Morton D., Keighley M.R., Goh J. The outcome of surgery in fulminant Clostridium difficile colitis. Colorectal Dis 2006, 8(February (2)):149-154.
42. Morris A.M., Jobe B.A., Stoney M., Sheppard B.C., Deveney C.W., Deveney K.E. Clostridium difficile colitis: an increasingly aggressive iatrogenic disease?. Arch Surg 2002, 137(October (10)):1096-1100.
43. Belmares J., Gerding D.N., Parada J.P., Miskevics S., Weaver F., Johnson S. Outcome of metronidazole therapy for Clostridium difficile disease and correlation with a scoring system. J Infect 2007, 55(December (6)):495-501.
44. Musher D.M., Aslam S., Logan N., Nallacheru S., Bhaila I., Borchert F., et al. Relatively poor outcome after treatment of Clostridium difficile colitis with metronidazole. Clin Infect Dis 2005, 40(June (11)):1586-1590.
45. Nair S., Yadav D., Corpuz M., Pitchumoni C.S. Clostridium difficile colitis: factors influencing treatment failure and relapse - a prospective evaluation. Am J Gastroenterol 1998, 93(October (10)):1873-1876.
46. Olson M.M., Shanholtzer C.J., Lee J.T., Gerding D.N. Ten years of prospective Clostridium difficile-associated disease surveillance and treatment at the Minneapolis VA Medical Center, 1982-1991. Infect Control Hosp Epidemiol 1994, 15(June (6)):371-381.
47. Pepin J., Alary M.E., Valiquette L., Raiche E., Ruel J., Fulop K., et al. Increasing risk of relapse after treatment of Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis 2005, 40(June (11)):1591-1597.
48. Teasley D.G., Gerding D.N., Olson M.M., Peterson L.R., Gebhard R.L., Schwartz M.J., et al. Prospective randomised trial of metronidazole versus vancomycin for Clostridium-difficile-associated diarrhoea and colitis. Lancet 1983, 2(November (8358)):1043-1046.
49. Wenisch C., Parschalk B., Hasenhundl M., Hirschl A.M., Graninger W. Comparison of vancomycin, teicoplanin, metronidazole, and fusidic acid for the treatment of Clostridium difficile-associated diarrhea. Clin Infect Dis 1996, 22(May (5)):813-818.
50. Zar F.A., Bakkanagari S.R., Moorthi K.M., Davis M.B. A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile-associated diarrhea, stratified by disease severity. Clin Infect Dis 2007, 45(August (3)):302-307.
51. de Lalla F., Nicolin R., Rinaldi E., Scarpellini P., Rigoli R., Manfrin V., et al. Prospective study of oral teicoplanin versus oral vancomycin for therapy of pseudomembranous colitis and Clostridium difficile-associated diarrhea. Antimicrob Agents Chemother 1992, 36(October (10)):2192-2196.
52. Dudley M.N., McLaughlin J.C., Carrington G., Frick J., Nightingale C.H., Quintiliani R. Oral bacitracin vs vancomycin therapy for Clostridium difficile-induced diarrhea. A randomized double-blind trial. Arch Intern Med 1986, 146(June (6)):1101-1104.
53. Young G.P., Ward P.B., Bayley N., Gordon D., Higgins G., Trapani J.A., et al. Antibiotic-associated colitis due to Clostridium difficile: double-blind comparison of vancomycin with bacitracin. Gastroenterology 1985, 89(November (5)):1038-1045.
54. McFarland L.V., Elmer G.W., Surawicz C.M. Breaking the cycle: treatment strategies for 163 cases of recurrent Clostridium difficile disease. Am J Gastroenterol 2002, 97(July (7)):1769-1775.