Journal article

Galactomannan and PCR versus culture and histology for directing use of antifungal treatment for invasive aspergillosis in high-risk haematology patients: a randomised controlled trial

C Orla Morrissey, Sharon C-A Chen, Tania C Sorrell, Samuel Milliken, Peter G Bardy, Kenneth F Bradstock, Jeffrey Szer, Catriona L Halliday, Nicole M Gilroy, John Moore, Anthony P Schwarer, Stephen Guy, Ashish Bajel, Adrian R Tramontana, Timothy Spelman, Monica A Slavin

LANCET INFECTIOUS DISEASES | ELSEVIER SCI LTD | Published : 2013

Abstract

BACKGROUND: Empirical treatment with antifungal drugs is often used in haematology patients at high risk of invasive aspergillosis. We compared a standard diagnostic strategy (culture and histology) with a rapid biomarker-based diagnostic strategy (aspergillus galactomannan and PCR) for directing the use of antifungal treatment in this group of patients. METHODS: In this open-label, parallel-group, randomised controlled trial, eligible patients were adults undergoing allogeneic stem-cell transplantation or chemotherapy for acute leukaemia, with no history of invasive fungal disease. Enrolled patients were randomly assigned (1:1) by a computer-generated schedule to follow either a standard di..

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Grants

Awarded by Australian National Health and Medical Research Council (NHMRC) Project


Awarded by NHMRC Centre for Clinical Research Excellence in Infectious Diseases, Royal Melbourne Hospital, Melbourne, VIC, Australia


Awarded by NHMRC Centre for Clinical Research Excellence in Infections, Bioethics and Haematological Malignancies, Westmead Millennium Institute, University of Sydney, Sydney, NSW, Australia


Funding Acknowledgements

Funding Australian National Health and Medical Research Council, Cancer Council New South Wales, Pfizer, Merck, Gilead Sciences.COM has been a member of advisory boards for, received investigator-initiated grants from, and given lectures for Gilead Sciences, Pfizer, Merck Sharp & Dohme, and Orphan Australia. SC-AC has received investigator-initiated grants from and been a member of advisory boards for Pfizer, Gilead Sciences, and Merck Sharp & Dohme. TCS has been a member of advisory boards for and has received investigator-initiated grants from Pfizer and Merck Sharp & Dohme. KFB has received consultancy payments from Pfizer, Merck Sharp & Dohme, and Gilead Sciences. NMG has been a member of advisory boards for Schering Plough (2006) and Pfizer (2012) and has given talks at events sponsored by Pfizer, Merck Sharp & Dohme, and Gilead Sciences. AB received a travel grant to a conference from Merck Sharp & Dohme. ART has received a travel grant to a conference from Pfizer. MAS has been a member of advisory boards for and received research funding from Pfizer, Merck Sharp & Dohme, Schering Plough, and Gilead Sciences. SM, PGB, JS, CLH, JM, APS, SG, and TS declare that they have no conflicts of interest.These findings were presented in part at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (Chicago, IL, USA, Sept 17-20,2011). We thank the trial coordinators (N Griffiths, E J Furphy, S Firth, T Luff, C Kesby, P Plenge, D Barham, M Antipas, T Lewis), laboratory research assistants (S Sleiman, G Kularatne, A Campbell, A-L Chan, S Kidd), and data managers (A Matera, T Morgan, J Di Iulio) for their important contributions to the trial. This work was supported by grants from the Australian National Health and Medical Research Council (NHMRC) Project Grant (331305) and Cancer Council New South Wales. We are also grateful to Pfizer for a large, unrestricted, investigator-initiated grant and to Merck Sharp & Dohme (Australia) and Gilead Sciences, who provided minor, unrestricted, investigator-initiated grants for this trial. Funding was also provided by the NHMRC Centre for Clinical Research Excellence in Infectious Diseases (219275), Royal Melbourne Hospital, Melbourne, VIC, Australia; the NHMRC Centre for Clinical Research Excellence in Infections, Bioethics and Haematological Malignancies (264625), Westmead Millennium Institute, University of Sydney, Sydney, NSW, Australia; Bio-Rad, Marnes-la-Coquette, France; and Sigma-Aldrich Company, St Louis, MO, USA. The Victorian Operational Infrastructure Support Program received by the Burnet Institute provided infrastructure support for this trial. Without all of these funding sources the trial would not have been completed. TCS is a Sydney Medical School Foundation Fellow.