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Prospective, randomised, double-blind, placebo-controlled phase III trial on voriconazole as primary antifungal prophylaxis during induction chemotherapy for acute myelogenous leukaemia

Abstract number: 1733_474

Vehreschild J., Mousset S., Hummel M., Arenz D., Wassmer G., Harnischmacher U., Ullmann A., Buchheidt D., Böhme A., Cornely O.

Background: Invasive fungal infections remain a frequent cause of morbidity and mortality in long-term neutropenic patients. The availability of tolerable broad-spectrum antifungals like voriconazole reignited the discussion about the best timing of antifungal therapy. We therefore conducted a trial to analyze the efficacy and safety of voriconazole in the prevention of lung infiltrates during induction chemotherapy for acute myelogenous leukaemia (AML).

Methods: Prospective, randomised, double-blind, placebo-controlled phase III trial in AML patients undergoing first remission induction chemotherapy. Voriconazole 200 mg BID or placebo were administered until detection of a lung infiltrate or end of neutropenia. Primary objective was the incidence of lung infiltrates until day 21, i.e. the start of 2nd induction chemotherapy.

Results: 25 patients were randomised to voriconazole (N = 10) or placebo (N = 15). Incidence of lung infiltrates until day 21 was 0 (0%) in the voriconazole vs. 5 (33%) in the placebo treatment arm (chi2 test, p = 0.04). Incidences of chronic disseminated candidiasis at 4 week follow-up was 0 (0%) in the voriconazole vs. 4 (27%) in the placebo treatment group (chi2 test, p = 0.07).

Conclusion: In this randomised, double-blind, placebo-controlled trial voriconazole 200 mg BID PO reduced the incidence of lung infiltrates during AML induction chemotherapy. There was a trend towards a lower incidence of chronic disseminated candidiasis in the voriconazole arm.

Session Details

Date: 31/03/2007
Time: 00:00-00:00
Session name: European Society of Clinical Microbiology and Infectious Diseases
Subject:
Location: ICC, Munich, Germany
Presentation type:
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