Microsoft word - protokoll sekundärprophylaxe englisch 291003.doc

Protocol
“Epidemiology of Secondary Prophylaxis of Invasive Fungal Infection”
from the Infectious Disease Working Group of the
German Society for Hematology and Oncology
Introduction
Primary Prophylaxis. The antifungal primary prophylaxis in cancer patients has been examined in numerous trials1. For patients undergoing allogeneic bone marrow trans- plantation a reduction of the incidence and mortality could be shown2-4. These benefits were achieved under fluconazole 400mg qd. However, fluconazole is not effective against Aspergillus spp. and has no satisfying efficacy against certain Candida spp. At the moment the clinical value of other antifungals for primary antifungal prophylaxis Secondary Prophylaxis. Patients, who survived an invasive fungal infection, and un- dergo another deeply neutropenic treatment phase, a high risk for recurrent fungal in- fection must be reckoned with. Reliable prospective evaluations defining this risk are not yet available. Currently, diverse antifungal prophylactic regimens are applied an clinicians rely on personal experience. Valid descriptions of the type and effectivity of Objectives
The objective of this evaluation is to describe the methods and the success rates of cur- rent antifungal secondary prophylactic strategies by focusing on the following topics: 1. To determine the relative frequency of relapses of invasive fungal infections in the 2. To describe the secondary prophylactic regimens applied in the participating cen- 3. To determine the efficacy of the secondary prophylactic regimens. Study period
The study will end after inclusion of 500 evaluable patients. Patient definition (see Amendments 1 & 2)
• history of proven or probable invasive fungal infection • acute myelogenous leukemia (AML), i.e. de novo, relapse, or secondary In the beginning phase of the evaluation patients with acute lymphatic leukemia, lymphoma, and solid tumor will not be included. • on secondary prophylaxis after October 1, 2001 Amendment 1:
From January 1, 2002 the inclusion of patients with acute lymphatic leukemia is
allowed.
Amendment 2:
From February 1, 2002 patients with proven invasive fungal infection can be in-
cluded retrospectively and will be evaluated separately.
• history of possible invasive fungal infection, but not of proven or probable invasive Case report from
The CRF is an internet based form to be accessed under www.neutropen.de. Pull-down menus and data transfer via email simplify its use. Data will automatically be incorpo- rated into a Filemaker Pro 4.0™ database5. Data evaluated comprise: • concerning first invasive fungal infection (IFI): fungal species, organs involved, treatment, treatment results of IFI and of malig- nancy, treatment delay attributable to IFI • concerning the secondary prophylaxis: identical to first IFI, plus: start and end of prophylaxis, antifungals used room conditions, i.e. laminar air flow, HEPA filter use, exposition to construction work and dust, status of the underlying malignancy at the beginning of the secon- dary prophylaxis, duration of neutropenia, mucositis grade 3-4 (CTC), diabetes mellitus, central venous catheter, total parenteral nutrition, high dose cytosine ara- binoside, steroids >2mg/kg >7 days, anti-thymocyte-, -lymphocyte- or CD3- antibodies, purine analogues, number of antibiotics, and number of days with anti- • concerning any second IFI: yes/no, species, organ involvement, treatment result of underlying malignancy and second IFI, survival, if applicable cause of death, and Evaluation and statistical considerations
The evaluation will be descriptive. For differences between subgroups χ²-test or exact test of Fisher will be used with a p<0.05 as limit for statistical significance. Budgetary information
For evaluable CRFs a compensation of € 130 will be paid for each evaluable documen- Contacts
References
Kern WV, Beyer J, Bohme A, et al. [Prophylaxis of infection in neutropenic pa- tients. Guidelines of the Working Party on Infections in Hematology and On- cology]. Dtsch Med Wochenschr 2000; 125:1582-8. Goodman JL, Winston DJ, Greenfield RA, et al. A controlled trial of flucona- zole to prevent fungal infections in patients undergoing bone marrow transplan- tation [see comments]. N Engl J Med 1992; 326:845-51. Marr KA, Seidel K, Slavin MA, et al. Prolonged fluconazole prophylaxis is as- sociated with persistent protection against candidiasis-related death in alloge- neic marrow transplant recipients: long-term follow-up of a randomized, pla- cebo-controlled trial. Blood. 2000; 96:2055-61. Slavin MA, Osborne B, Adams R, et al. Efficacy and safety of fluconazole pro- phylaxis for fungal infections after marrow transplantation--a prospective, ran- domized, double-blind study. J Infect Dis 1995; 171:1545-52. FileMaker Pro. Santa Clara, Ca.: Claris Corporation, 2000.

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