Criteria for enrollment: Randomized comparison of Voriconazole and Amphotericin B in primary therapy of invasive aspergillosis


Denning DW


Principal investigators: David W. Denning, Raoul Herbrecht, Thomas F. Patterson, John E. Bennett The criteria were drafted by David Denning in 1996 and modified by consultation with many experts over the following 12 months prior to the study start in 1997. These discussions were made possible by Pfizer who have invested hugely in these successful studies. They preceded the new definitions proposed by the EORTC IFIG and Mycoses Study Group which were developed between 1998-2000. Two protocols were run with the criteria below, laid out slightly differently between the 2 protocols. All enrolled cases were analysed subsequently by Data Review Committee (blinded to drug received and unblinding side effects), and all radiographs and scans by 4 radiologists all working to common carefully predefined standards for inclusion criteria and response. The table at the end is intended as an ‘aide memoire’ and should be read from the top down. In the protocols it was an appendix summary.The results of the study will be presented at ICAAC 2001 and submitted for publication late in 2001.