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

The Lancet Infectious Diseases

Volumn 13, Issue 6, 2013, Pages 519-528

  Morrissey, C Orla ^a,l   Chen, Sharon C A ^b,c,d   Sorrell, Tania C ^b,c,d   Milliken, Samuel ^e   Bardy, Peter G ^f,g   Bradstock, Kenneth F ^b   Szer, Jeffrey ^h   Halliday, Catriona L ^b   Gilroy, Nicole M ⁱ   Moore, John ^e   Schwarer, Anthony P ^j,k   Guy, Stephen ^j   Bajel, Ashish ^h   Tramontana, Adrian R ^b   Spelman, Timothy ^a,c   Slavin, Monica A ^c,h,m  

^a MONASH UNIVERSITY   (Australia)

^b WESTMEAD HOSPITAL   (Australia)

^c WESTMEAD HOSPITAL   (Australia)

^d UNIVERSITY OF SYDNEY   (Australia)

^e ST VINCENT S HOSPITAL   (Australia)

^f ROYAL ADELAIDE HOSPITAL   (Australia)

^g QUEEN ELIZABETH HOSPITAL   (Australia)

^h ROYAL MELBOURNE HOSPITAL   (Australia)

ⁱ Musculoskeletal Network   (Australia)

^j Department of Haematology ^*  (Australia)

^k BOX HILL HOSPITAL   (Australia)

^l BURNET INSTITUTE   (Australia)

^m PETER MACCALLUM CANCER CENTRE   (Australia)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AMPHOTERICIN B LIPID COMPLEX; ANTIFUNGAL AGENT; ANTINEOPLASTIC AGENT; FLUCONAZOLE; GALACTOMANNAN; ITRACONAZOLE; POSACONAZOLE; VORICONAZOLE;

ACUTE LEUKEMIA; ADULT; ALLOGENEIC STEM CELL TRANSPLANTATION; ARTICLE; CANCER CHEMOTHERAPY; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED STUDY; DIAGNOSTIC TEST ACCURACY STUDY; ELISA KIT; FEMALE; FUNGUS CULTURE; HIGH RISK PATIENT; HISTOPATHOLOGY; HUMAN; INFECTION PREVENTION; INTERMETHOD COMPARISON; INVASIVE ASPERGILLOSIS; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEPHROTOXICITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REAL TIME POLYMERASE CHAIN REACTION; TREATMENT OUTCOME;

ADULT; ANTIFUNGAL AGENTS; ASPERGILLOSIS; ASPERGILLUS; BIOLOGICAL MARKERS; FEMALE; FOLLOW-UP STUDIES; HUMANS; LEUKEMIA, LYMPHOID; MALE; MANNANS; MIDDLE AGED; POLYMERASE CHAIN REACTION; STEM CELL TRANSPLANTATION; TRANSPLANTATION, HOMOLOGOUS;

EID: 84878465978     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(13)70076-8     Document Type: Article

References (35)

1. Neofytos D, Horn D, Anaissie E, et al. Epidemiology and outcome of invasive fungal infections in adult hematopoietic stem cell transplant recipients: analysis of multicenter prospective antifungal therapy (PATH) alliance registry. Clin Infect Dis 2009, 48:265-273.
2. Maertens JA, Nucci M, Donnelly JP The role of antifungal treatment in hematology. Haematologica 2012, 97:325-327.
3. Hughes WT, Armstrong D, Bodey GP, et al. 2002 guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis 2002, 34:730-751.
4. Halliday C, Hoile R, Sorrell T, et al. Role of prospective screening of blood for invasive aspergillosis by polymerase chain reaction in febrile neutropenic recipients of haematopoietic stem cell transplant and patients with acute leukaemia. Br J Haematol 2006, 132:478-486.
5. Maertens J, Van Eldere J, Verhaegen J, Verbeken E, Verschakelen J, Boogaerts M Use of circulating galactomannan screening for early diagnosis of invasive aspergillosis in allogeneic stem cell transplant recipients. J Infect Dis 2002, 186:1297-1306.
6. Maertens J, Theunissen K, Verhoef G, et al. Galactomannan and computed tomography-based preemptive antifungal therapy in neutropenic patients at high-risk for invasive fungal infection: a prospective feasibility study. Clin Infect Dis 2005, 41:1242-1250.
7. Barnes RA, White PL, Bygrave C, Evans N, Healy B, Kell J Clinical impact of enhanced diagnosis of invasive fungal disease in high-risk haematology and stem cell transplant patients. J Clin Pathol 2009, 62:64-69.
8. Hebart H, Klingspor L, Klingebiel T, et al. A prospective randomized controlled trial comparing PCR-based and empirical treatment with liposomal amphotericin B in patients after allo-SCT. Bone Marrow Transplant 2009, 43:553-561.
9. Cordonnier C, Pautas C, Maury S, et al. Empirical versus preemptive antifungal therapy for high-risk, febrile neutropenic patients: a randomized, controlled trial. Clin Infect Dis 2009, 48:1042-1051.
10. Tan BH, Low JG, Chlebicka NL, et al. Galactomannan-guided preemptive vs. empirical antifungals in the persistently febrile neutropenic patient: a prospective randomized study. Int J Infect Dis 2011, 15:350-356.
11. Blennow O, Remberger M, Klingspor L, et al. Randomized PCR-based therapy and risk factors for invasive fungal infection following reduced-intensity conditioning and hematopoietic SCT. Bone Marrow Transplant 2010, 45:1710-1718.
12. Dignan FL, Evans SO, Ethell ME, et al. An early CT-diagnosis-based treatment strategy for invasive fungal infection in allogeneic transplant recipients using caspofungin first line: an effective strategy with low mortality. Bone Marrow Transplant 2009, 44:51-56.
13. Morrissey CO, Chen SC, Sorrell TC, et al. Design issues in a randomized controlled trial of a pre-emptive versus empiric antifungal strategy for invasive aspergillosis in patients with high-risk hematologic malignancies. Leuk Lymphoma 2011, 52:179-193.
14. Maertens J, Verhaegen J, Demuynck H, et al. Autopsy-controlled prospective evaluation of serial screening for circulating galactomannan by a sandwich enzyme-linked immunosorbent assay for haematological patients at-risk for invasive aspergillosis. J Clin Microbiol 1999, 37:3223-3228.
15. Halliday CH, Wu QX, James G, Sorrell T Development of a nested qualitative real-time PCR assay to detect Aspergillus species DNA in clinical specimens. J Clin Microbiol 2005, 43:5366-5368.
16. de Pauw B, Walsh TJ, Donnelly JP, et al. Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infection Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Clin Infect Dis 2008, 46:1813-1821.
17. Slavin MA, Szer J, Grigg AP, et al. Guidelines for the use of antifungal agents in the treatment of invasive Candida and mould infections. Intern Med J 2004, 34:192-200.
18. Nivoix Y, Velten M, Letscher-Bru V, et al. Factors associated with overall and attributable mortality in invasive aspergillosis. Clin Infect Dis 2008, 47:1176-1184.
19. Severens JL, Donnelly JP, Meis JF, et al. Two strategies for managing invasive aspergillosis: a decision analysis. Clin Infect Dis 1997, 25:1148-1154.
20. Maertens J, Marchetti O, Herbrecht R, et al. European guidelines for antifungal management in leukemia and hematopoietic stem cell transplant recipients: summary of the ECIL-3 2009 Update. Bone Marrow Transplant 2011, 46:709-718.
21. Caillot D, Casasnovas O, Bernard A, et al. Improved management of invasive pulmonary aspergillosis in neutropenic patients using early thoracic computed tomographic scan and surgery. J Clin Oncol 1997, 15:139-147.
22. Greene RE, Schlamm HT, Oestmann JW, et al. Imaging findings in acute invasive pulmonary aspergillosis: clinical significance of the halo sign. Clin Infect Dis 2007, 44:373-379.
23. Guyatt GH, Tugwell PX, Feeny DH, Haynes RB, Drummond M A framework for clinical evaluation of diagnostic technologies. CMAJ 1986, 134:587-594.
24. White PL, Bretagne S, Klingspor L, et al. Aspergillus PCR: one step closer to standardization. J Clin Microbiol 2010, 48:1231-1240.
25. Wingard JR, Carter SL, Walsh TJ, et al. Randomized, double-blind trial of fluconazole versus voriconazole for prevention of invasive fungal infection after allogeneic hematopoietic stem cell transplantation. Blood 2010, 116:5111-5118.
26. Marr KA, Laverdiere M, Gugel A, Leisenring W Antifungal therapy decreases sensitivity of the Aspergillus galactomannan enzyme immunoassay. Clin Infect Dis 2005, 40:1762-1769.
27. Buchheidt D, Hummel M, Schleiermacher D, et al. Prospective clinical evaluation of a LightCycler-mediated polymerase chain reaction assay, a nested-PCR assay and a galactomannan enzyme-linked immunosorbent assay for detection of invasive aspergillosis in neutropenic cancer patients and haematological stem cell transplant recipients. Br J Haematol 2004, 125:196-202.
28. Ullmann AJ, Lipton JH, Vesole DH, et al. Posaconazole or fluconazole for prophylaxis in sever graft-versus-host disease. N Engl J Med 2007, 356:335-347.
29. Marr KA, Crippa F, Leisenring W, et al. Itraconazole versus fluconazole for prevention of fungal infections in patients receiving allogeneic stem cell transplants. Blood 2004, 103:1527-1533.
30. Vardakas KZ, Michalopoulos A, Falagas ME Fluconazole versus itraconazole for antifungal prophylaxis in neutropenic patients with haematological malignancies: a meta-analysis of randomised-controlled trials. Br J Haematol 2005, 131:22-28.
31. Morrissey CO, Bardy PG, Slavin MA, et al. Diagnostic and therapeutic approach to persistent or recurrent fevers of unknown origin in adult stem cell transplantation and haematological malignancy. Intern Med J 2008, 38:477-495.
32. Hebart H, Loffler J, Meisner C, et al. Early detection of Aspergillus infection after allogeneic stem cell transplantation by polymerase chain reaction screening. J Infect Dis 2000, 181:1713-1719.
33. Murray P, Kerridge I, Tiley C, et al. Enrolment of patients to clinical trials in haematological cancer in New South Wales: current status, perceived barriers and opportunities for improvement. Intern Med J 2010, 40:133-138.
34. Biau DJ, Halm JA, Ahmadieh H, et al. Provider and center effect in multi-center randomized controlled trials of surgical specialities: an analysis on patient-level data. Ann Surg 2008, 247:892-898.
35. Agrawal S, Hope W, Sinko J, Kibbler C Optimizing management of invasive mould diseases. J Antimicrob Chemother 2011, 66(suppl 1):145-153.