TY - JOUR
T1 - Forum report
T2 - Issues in clinical trials of empirical antifungal therapy in treating febrile neutropenic patients
AU - Bennett, John E.
AU - Powers, John
AU - Walsh, Thomas
AU - Viscoli, Claudio
AU - De Pauw, Ben
AU - Dismukes, William
AU - Galgiani, John
AU - Glauser, Michel
AU - Herbrecht, Raoul
AU - Kauffman, Carol
AU - Lee, Jeannette
AU - Pappas, Peter
AU - Rex, John
AU - Verweij, Paul
PY - 2003/4/15
Y1 - 2003/4/15
N2 - There is inferential evidence that some patients with prolonged neutropenia and fever not responding to antibacterial agents are at sufficient risk of deep mycoses to warrant empirical therapy, although superiority of an antifungal agent over placebo has not been conclusively demonstrated. Amphotericin B deoxycholate, liposomal amphotericin B, and intravenous itraconazole followed by oral itraconazole solution are licensed in the United States for this indication. Fluconazole and voriconazole have given favorable results in clinical trials of patients with low and high risk of deep mold infections, respectively. Design features that can profoundly influence outcome of empirical trials are (1) inclusion of low-risk patients, (2) failure to blind the study, (3) obscuration of antifungal effects by changing antibacterial antibiotics, (4) failure to balance both arms of the study in terms of patients with prior antifungal prophylaxis or with severe comorbidities, (5) the merging of end points evaluating safety with those of efficacy, and (6) choice of different criteria for resolution of fever.
AB - There is inferential evidence that some patients with prolonged neutropenia and fever not responding to antibacterial agents are at sufficient risk of deep mycoses to warrant empirical therapy, although superiority of an antifungal agent over placebo has not been conclusively demonstrated. Amphotericin B deoxycholate, liposomal amphotericin B, and intravenous itraconazole followed by oral itraconazole solution are licensed in the United States for this indication. Fluconazole and voriconazole have given favorable results in clinical trials of patients with low and high risk of deep mold infections, respectively. Design features that can profoundly influence outcome of empirical trials are (1) inclusion of low-risk patients, (2) failure to blind the study, (3) obscuration of antifungal effects by changing antibacterial antibiotics, (4) failure to balance both arms of the study in terms of patients with prior antifungal prophylaxis or with severe comorbidities, (5) the merging of end points evaluating safety with those of efficacy, and (6) choice of different criteria for resolution of fever.
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U2 - 10.1086/367839
DO - 10.1086/367839
M3 - Article
C2 - 12679895
AN - SCOPUS:0037446938
SN - 1058-4838
VL - 36
SP - S117-S122
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - SUPPL. 3
ER -