BACKGROUND: Assessment of response to invasive aspergillosis (IA) therapy has been challenging in treatment trials. METHODS: The causes of death over 12 weeks were categorized prospectively by a blinded data review committee using a priori defined criteria in participants in a randomized comparative trial of voriconazole versus amphotericin B as first-line therapy of proven or probable IA. RESULTS:Death occurred in 98 of 277 patients during the 12-week course of study. Seventy-three of the 98 deaths (74%) occurred in the first 6 weeks; 25 deaths occurred during the second 6 weeks. Of the 73 deaths during the first 6 weeks, 50 (68%) were judged to be attributable to IA. Of the 25 deaths during the second 6 weeks, only 6 (24%) were judged to be attributable to IA. Fifty of the 56 deaths (89%) attributable to IA occurred during the first 6 weeks. CONCLUSIONS: These data suggest that most deaths due to IA occur during the first 6 weeks after the start of therapy and 6 weeks may be a better interval to judge the effectiveness of antifungal therapy because most deaths after 6 weeks are due to causes related to the underlying disease and its treatment rather than due to IA. Attributable mortality when assessed using a priori definitions and conducted in a blinded manner by a central data review committee can be useful in the assessment of IA therapy. (c) 2008 American Cancer Society.
RCT Entities:
BACKGROUND: Assessment of response to invasive aspergillosis (IA) therapy has been challenging in treatment trials. METHODS: The causes of death over 12 weeks were categorized prospectively by a blinded data review committee using a priori defined criteria in participants in a randomized comparative trial of voriconazole versus amphotericin B as first-line therapy of proven or probable IA. RESULTS:Death occurred in 98 of 277 patients during the 12-week course of study. Seventy-three of the 98 deaths (74%) occurred in the first 6 weeks; 25 deaths occurred during the second 6 weeks. Of the 73 deaths during the first 6 weeks, 50 (68%) were judged to be attributable to IA. Of the 25 deaths during the second 6 weeks, only 6 (24%) were judged to be attributable to IA. Fifty of the 56 deaths (89%) attributable to IA occurred during the first 6 weeks. CONCLUSIONS: These data suggest that most deaths due to IA occur during the first 6 weeks after the start of therapy and 6 weeks may be a better interval to judge the effectiveness of antifungal therapy because most deaths after 6 weeks are due to causes related to the underlying disease and its treatment rather than due to IA. Attributable mortality when assessed using a priori definitions and conducted in a blinded manner by a central data review committee can be useful in the assessment of IA therapy. (c) 2008 American Cancer Society.
Authors: John W Baddley; David R Andes; Kieren A Marr; Dimitrios P Kontoyiannis; Barbara D Alexander; Carol A Kauffman; Robert A Oster; Elias J Anaissie; Thomas J Walsh; Mindy G Schuster; John R Wingard; Thomas F Patterson; James I Ito; O Dale Williams; Tom Chiller; Peter G Pappas Journal: Clin Infect Dis Date: 2010-06-15 Impact factor: 9.079
Authors: Brahm H Segal; Raoul Herbrecht; David A Stevens; Luis Ostrosky-Zeichner; Jack Sobel; Claudio Viscoli; Thomas J Walsh; Johan Maertens; Thomas F Patterson; John R Perfect; Bertrand Dupont; John R Wingard; Thierry Calandra; Carol A Kauffman; John R Graybill; Lindsey R Baden; Peter G Pappas; John E Bennett; Dimitrios P Kontoyiannis; Catherine Cordonnier; Maria Anna Viviani; Jacques Bille; Nikolaos G Almyroudis; L Joseph Wheat; Wolfgang Graninger; Eric J Bow; Steven M Holland; Bart-Jan Kullberg; William E Dismukes; Ben E De Pauw Journal: Clin Infect Dis Date: 2008-09-01 Impact factor: 9.079
Authors: Donald C Vinh; Yvonne R Shea; Pamela A Jones; Alexandra F Freeman; Adrian Zelazny; Steven M Holland Journal: Emerg Infect Dis Date: 2009-08 Impact factor: 6.883