Randomized Controlled Trial of Two Diagnostic Strategies for Invasive Aspergillosis (IA) in High-Risk Hematology Patients

Ref ID: 18660

Author:

O. Morrissey, M.B., B.Ch., FRACP, Ph.D – Infectious Diseases Physician1, S. Chen – Infectious Diseases Physician 2, M. Slavin – Infectious Diseases Physician 3, Australia and New Zealand Mycology Interest Group, Australasian Leukaemia Lymphoma Group;

Author address:

1Alfred Hosp., Melbourne, Australia, 2Westmead Hosp., Sydney, Australia, 3Peter MacCallum Cancer Ctr., Melbourne, Australia.

Full conference title:

52nd Annual ICAAC

Date: 9 September 2014

Abstract:

Background: IA is a major cause of mortality in patients with hematological malignancies. As culture-based diagnosis is insensitive, empiric antifungal therapy (EAFT) is used to treat persistent febrile neutropenia (PFN) with high attendant mortality and toxicity rates and costs. Herein, we examine the impact of 2 new diagnostic assays – the Aspergillus PCR and galactomannan enzyme immunoassay (GM-ELSA) – in guiding antifungal therapy (AFT). Methods: Adults (≥ 18 yo) either undergoing allogeneic stem cell transplant (allo-SCT) or chemotherapy for acute leukemia were randomized 1:1 to either the standard diagnostic (SD) strategy or an Aspergillus PCR and GM-ELISA guided pre-emptive (PE) strategy. In the SD arm AFT was directed by PFN and the results of high-resolution (HR) chest CT scans, cultures and biopsies. Twice-weekly PCR and GM-ELISA results in the PE arm directed AFT and the performance of chest HRCT scans. Each patient was followed for 26 w or until death. The primary end-point was the proportion that received EAFT as assessed by an independent data review committee. Results: 122 and 118 were randomized to the SD and PE arms, respectively. Most were allo-SCT recipients (92 vs. 99, p>0.1). Median age and number of males did not differ between arms (49 y vs. 47.5 y, p=0.14; 82 vs. 67, p>0.1). Significantly more in the SD arm received EAFT (39 vs. 18, p=0.002). Significantly more probable IA was diagnosed in the PE arm (0 vs. 16, p<0.001). There was no difference between the arms in overall and IA-related deaths (18 vs. 12, p=0.28; 6 vs. 3, p=0.5, respectively). Overall duration and cost of AFT did not significantly differ between the arms (median 11 d vs. 12 d, p=0.87; A$505.92 vs. A$624.84, p=0.22). No differences in nephrotoxicity and hepatotoxicity rates were detected. Conclusions: PE strategy significantly reduced EAFT use. Despite more cases of IA in the PE arm; no increases in mortality rates or duration and costs of AFT were detected.

Abstract Number: M-1136

Conference Year: 2012

Link to conference website: NULL

New link: NULL

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