Antifungal Use in Oncohematological Neutropenic Patients

Summary

Primary purpose: Frequency of use of broad-spectrum antifungals in the episode of neutropenia. Secondary purposes:To determine the safety and toxicity measure by: 1. Frequency of Invader Fungal Infection. 2. Frequency of global use of broad-spectrum antifungals as amphotericine, itraconazole, voriconazole, caspofungin, terbinafine, during the period of study. 3. Mortality 4. Development of nephrotoxicity 5. Use of galactomannan in this clinical context 6. Time of administration of empirical antifungal therapy of broad-spectrum.

Timeline

Start

2006-08

Primary completion

2008-12

Completion

2009-01

Publications

• Background Kami M, Machida U, Okuzumi K, Matsumura T, Mori Si S, Hori A, Kashima T, Kanda Y, Takaue Y, Sakamaki H, Hirai H, Yoneyama A, Mutou Y. Effect of fluconazole prophylaxis on fungal blood cultures: an autopsy-based study involving 720 patients with haematological malignancy. Br J Haematol. 2002 Apr;117(1):40-6. doi: 10.1046/j.1365-2141.2002.03414.x.
• Background Young RC, Bennett JE, Vogel CL, Carbone PP, DeVita VT. Aspergillosis. The spectrum of the disease in 98 patients. Medicine (Baltimore). 1970 Mar;49(2):147-73. doi: 10.1097/00005792-197003000-00002. No abstract available.
• Background Groll AH, Shah PM, Mentzel C, Schneider M, Just-Nuebling G, Huebner K. Trends in the postmortem epidemiology of invasive fungal infections at a university hospital. J Infect. 1996 Jul;33(1):23-32. doi: 10.1016/s0163-4453(96)92700-0.
• Background Pizzo PA, Robichaud KJ, Gill FA, Witebsky FG. Empiric antibiotic and antifungal therapy for cancer patients with prolonged fever and granulocytopenia. Am J Med. 1982 Jan;72(1):101-11. doi: 10.1016/0002-9343(82)90594-0. No abstract available.
• Background Empiric antifungal therapy in febrile granulocytopenic patients. EORTC International Antimicrobial Therapy Cooperative Group. Am J Med. 1989 Jun;86(6 Pt 1):668-72. doi: 10.1016/0002-9343(89)90441-5.
• Background Wingard JR, Kubilis P, Lee L, Yee G, White M, Walshe L, Bowden R, Anaissie E, Hiemenz J, Lister J. Clinical significance of nephrotoxicity in patients treated with amphotericin B for suspected or proven aspergillosis. Clin Infect Dis. 1999 Dec;29(6):1402-7. doi: 10.1086/313498.
• Background Bates DW, Su L, Yu DT, Chertow GM, Seger DL, Gomes DR, Dasbach EJ, Platt R. Mortality and costs of acute renal failure associated with amphotericin B therapy. Clin Infect Dis. 2001 Mar 1;32(5):686-93. doi: 10.1086/319211. Epub 2001 Feb 21.
• Background Harbarth S, Burke JP, Lloyd JF, Evans RS, Pestotnik SL, Samore MH. Clinical and economic outcomes of conventional amphotericin B-associated nephrotoxicity. Clin Infect Dis. 2002 Dec 15;35(12):e120-7. doi: 10.1086/344468. Epub 2002 Dec 2.
• Background Walsh TJ, Teppler H, Donowitz GR, Maertens JA, Baden LR, Dmoszynska A, Cornely OA, Bourque MR, Lupinacci RJ, Sable CA, dePauw BE. Caspofungin versus liposomal amphotericin B for empirical antifungal therapy in patients with persistent fever and neutropenia. N Engl J Med. 2004 Sep 30;351(14):1391-402. doi: 10.1056/NEJMoa040446.
• Background Walsh TJ, Pappas P, Winston DJ, Lazarus HM, Petersen F, Raffalli J, Yanovich S, Stiff P, Greenberg R, Donowitz G, Schuster M, Reboli A, Wingard J, Arndt C, Reinhardt J, Hadley S, Finberg R, Laverdiere M, Perfect J, Garber G, Fioritoni G, Anaissie E, Lee J; National Institute of Allergy and Infectious Diseases Mycoses Study Group. Voriconazole compared with liposomal amphotericin B for empirical antifungal therapy in patients with neutropenia and persistent fever. N Engl J Med. 2002 Jan 24;346(4):225-34. doi: 10.1056/NEJM200201243460403.
• Background Malik IA, Moid I, Aziz Z, Khan S, Suleman M. A randomized comparison of fluconazole with amphotericin B as empiric anti-fungal agents in cancer patients with prolonged fever and neutropenia. Am J Med. 1998 Dec;105(6):478-83. doi: 10.1016/s0002-9343(98)00326-x.
• Background Viscoli C, Castagnola E, Van Lint MT, Moroni C, Garaventa A, Rossi MR, Fanci R, Menichetti F, Caselli D, Giacchino M, Congiu M. Fluconazole versus amphotericin B as empirical antifungal therapy of unexplained fever in granulocytopenic cancer patients: a pragmatic, multicentre, prospective and randomised clinical trial. Eur J Cancer. 1996 May;32A(5):814-20. doi: 10.1016/0959-8049(95)00619-2.
• Background Winston DJ, Hathorn JW, Schuster MG, Schiller GJ, Territo MC. A multicenter, randomized trial of fluconazole versus amphotericin B for empiric antifungal therapy of febrile neutropenic patients with cancer. Am J Med. 2000 Mar;108(4):282-9. doi: 10.1016/s0002-9343(99)00457-x.
• Background McLintock LA, Jordanides NE, Allan EK, Copland M, Stewart K, Parker A, Devaney M, Holyoake TL, Jones BL. The use of a risk group stratification in the management of invasive fungal infection: a prospective validation. Br J Haematol. 2004 Feb;124(3):403-4. doi: 10.1046/j.1365-2141.2003.04794.x. No abstract available.
• Background Wheat LJ. Rapid diagnosis of invasive aspergillosis by antigen detection. Transpl Infect Dis. 2003 Dec;5(4):158-66. doi: 10.1111/j.1399-3062.2003.00031.x.
• Background Mennink-Kersten MA, Donnelly JP, Verweij PE. Detection of circulating galactomannan for the diagnosis and management of invasive aspergillosis. Lancet Infect Dis. 2004 Jun;4(6):349-57. doi: 10.1016/S1473-3099(04)01045-X.
• Background Herbrecht R, Letscher-Bru V, Oprea C, Lioure B, Waller J, Campos F, Villard O, Liu KL, Natarajan-Ame S, Lutz P, Dufour P, Bergerat JP, Candolfi E. Aspergillus galactomannan detection in the diagnosis of invasive aspergillosis in cancer patients. J Clin Oncol. 2002 Apr 1;20(7):1898-906. doi: 10.1200/JCO.2002.07.004.
• Background Maertens J, Theunissen K, Verbeken E, Lagrou K, Verhaegen J, Boogaerts M, Eldere JV. Prospective clinical evaluation of lower cut-offs for galactomannan detection in adult neutropenic cancer patients and haematological stem cell transplant recipients. Br J Haematol. 2004 Sep;126(6):852-60. doi: 10.1111/j.1365-2141.2004.05140.x.
• Background Marr KA, Balajee SA, McLaughlin L, Tabouret M, Bentsen C, Walsh TJ. Detection of galactomannan antigenemia by enzyme immunoassay for the diagnosis of invasive aspergillosis: variables that affect performance. J Infect Dis. 2004 Aug 1;190(3):641-9. doi: 10.1086/422009. Epub 2004 Jul 1.
• Background Viscoli C, Machetti M, Cappellano P, Bucci B, Bruzzi P, Van Lint MT, Bacigalupo A. False-positive galactomannan platelia Aspergillus test results for patients receiving piperacillin-tazobactam. Clin Infect Dis. 2004 Mar 15;38(6):913-6. doi: 10.1086/382224. Epub 2004 Feb 27.
• Background Singh N, Obman A, Husain S, Aspinall S, Mietzner S, Stout JE. Reactivity of platelia Aspergillus galactomannan antigen with piperacillin-tazobactam: clinical implications based on achievable concentrations in serum. Antimicrob Agents Chemother. 2004 Jun;48(6):1989-92. doi: 10.1128/AAC.48.6.1989-1992.2004.
• Background Sulahian A, Boutboul F, Ribaud P, Leblanc T, Lacroix C, Derouin F. Value of antigen detection using an enzyme immunoassay in the diagnosis and prediction of invasive aspergillosis in two adult and pediatric hematology units during a 4-year prospective study. Cancer. 2001 Jan 15;91(2):311-8. doi: 10.1002/1097-0142(20010115)91:23.0.co;2-3.
• Background Maertens J, Van Eldere J, Verhaegen J, Verbeken E, Verschakelen J, Boogaerts M. Use of circulating galactomannan screening for early diagnosis of invasive aspergillosis in allogeneic stem cell transplant recipients. J Infect Dis. 2002 Nov 1;186(9):1297-306. doi: 10.1086/343804. Epub 2002 Oct 8.
• Background Heussel CP, Kauczor HU, Heussel GE, Fischer B, Begrich M, Mildenberger P, Thelen M. Pneumonia in febrile neutropenic patients and in bone marrow and blood stem-cell transplant recipients: use of high-resolution computed tomography. J Clin Oncol. 1999 Mar;17(3):796-805. doi: 10.1200/JCO.1999.17.3.796.
• Background Ascioglu S, Rex JH, de Pauw B, Bennett JE, Bille J, Crokaert F, Denning DW, Donnelly JP, Edwards JE, Erjavec Z, Fiere D, Lortholary O, Maertens J, Meis JF, Patterson TF, Ritter J, Selleslag D, Shah PM, Stevens DA, Walsh TJ; Invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer; Mycoses Study Group of the National Institute of Allergy and Infectious Diseases. Defining opportunistic invasive fungal infections in immunocompromised patients with cancer and hematopoietic stem cell transplants: an international consensus. Clin Infect Dis. 2002 Jan 1;34(1):7-14. doi: 10.1086/323335. Epub 2001 Nov 26.
• Background Walsh TJ, Finberg RW, Arndt C, Hiemenz J, Schwartz C, Bodensteiner D, Pappas P, Seibel N, Greenberg RN, Dummer S, Schuster M, Holcenberg JS. Liposomal amphotericin B for empirical therapy in patients with persistent fever and neutropenia. National Institute of Allergy and Infectious Diseases Mycoses Study Group. N Engl J Med. 1999 Mar 11;340(10):764-71. doi: 10.1056/NEJM199903113401004.
• Background Sociedad Espanola de Quimioterapia; Asociacion Espanola de Hematologia y Hemoterapia. [Prophylaxis and treatment of fungal infections in oncohematological patients]. Rev Esp Quimioter. 2002 Dec;15(4):387-401. No abstract available. Spanish.
• Background Herbrecht R, Denning DW, Patterson TF, Bennett JE, Greene RE, Oestmann JW, Kern WV, Marr KA, Ribaud P, Lortholary O, Sylvester R, Rubin RH, Wingard JR, Stark P, Durand C, Caillot D, Thiel E, Chandrasekar PH, Hodges MR, Schlamm HT, Troke PF, de Pauw B; Invasive Fungal Infections Group of the European Organisation for Research and Treatment of Cancer and the Global Aspergillus Study Group. Voriconazole versus amphotericin B for primary therapy of invasive aspergillosis. N Engl J Med. 2002 Aug 8;347(6):408-15. doi: 10.1056/NEJMoa020191.
• Background Pfaller MA, Diekema DJ; International Fungal Surveillance Participant Group. Twelve years of fluconazole in clinical practice: global trends in species distribution and fluconazole susceptibility of bloodstream isolates of Candida. Clin Microbiol Infect. 2004 Mar;10 Suppl 1:11-23. doi: 10.1111/j.1470-9465.2004.t01-1-00844.x.
• Background Pappas PG, Rex JH, Sobel JD, Filler SG, Dismukes WE, Walsh TJ, Edwards JE; Infectious Diseases Society of America. Guidelines for treatment of candidiasis. Clin Infect Dis. 2004 Jan 15;38(2):161-89. doi: 10.1086/380796. Epub 2003 Dec 19. No abstract available.
• Background Goodman JL, Winston DJ, Greenfield RA, Chandrasekar PH, Fox B, Kaizer H, Shadduck RK, Shea TC, Stiff P, Friedman DJ, et al. A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation. N Engl J Med. 1992 Mar 26;326(13):845-51. doi: 10.1056/NEJM199203263261301.
• Background Winston DJ, Chandrasekar PH, Lazarus HM, Goodman JL, Silber JL, Horowitz H, Shadduck RK, Rosenfeld CS, Ho WG, Islam MZ, Buell DN. Fluconazole prophylaxis of fungal infections in patients with acute leukemia. Results of a randomized placebo-controlled, double-blind, multicenter trial. Ann Intern Med. 1993 Apr 1;118(7):495-503. doi: 10.7326/0003-4819-118-7-199304010-00003.
• Background Rotstein C, Bow EJ, Laverdiere M, Ioannou S, Carr D, Moghaddam N. Randomized placebo-controlled trial of fluconazole prophylaxis for neutropenic cancer patients: benefit based on purpose and intensity of cytotoxic therapy. The Canadian Fluconazole Prophylaxis Study Group. Clin Infect Dis. 1999 Feb;28(2):331-40. doi: 10.1086/515128.
• Background Wolff SN, Fay J, Stevens D, Herzig RH, Pohlman B, Bolwell B, Lynch J, Ericson S, Freytes CO, LeMaistre F, Collins R, Pineiro L, Greer J, Stein R, Goodman SA, Dummer S. Fluconazole vs low-dose amphotericin B for the prevention of fungal infections in patients undergoing bone marrow transplantation: a study of the North American Marrow Transplant Group. Bone Marrow Transplant. 2000 Apr;25(8):853-9. doi: 10.1038/sj.bmt.1702233.
• Background Slavin MA, Osborne B, Adams R, Levenstein MJ, Schoch HG, Feldman AR, Meyers JD, Bowden RA. Efficacy and safety of fluconazole prophylaxis for fungal infections after marrow transplantation--a prospective, randomized, double-blind study. J Infect Dis. 1995 Jun;171(6):1545-52. doi: 10.1093/infdis/171.6.1545.
• Background MacMillan ML, Goodman JL, DeFor TE, Weisdorf DJ. Fluconazole to prevent yeast infections in bone marrow transplantation patients: a randomized trial of high versus reduced dose, and determination of the value of maintenance therapy. Am J Med. 2002 Apr 1;112(5):369-79. doi: 10.1016/s0002-9343(01)01127-5.
• Background Marr KA, Crippa F, Leisenring W, Hoyle M, Boeckh M, Balajee SA, Nichols WG, Musher B, Corey L. Itraconazole versus fluconazole for prevention of fungal infections in patients receiving allogeneic stem cell transplants. Blood. 2004 Feb 15;103(4):1527-33. doi: 10.1182/blood-2003-08-2644. Epub 2003 Oct 2.

Drugs

Indications