Journal Article

An open-label randomized trial comparing itraconazole oral solution with fluconazole oral solution for primary prophylaxis of fungal infections in patients with haematological malignancy and profound neutropenia

Axel Glasmacher, Oliver Cornely, Andrew J. Ullmann, Ulrich Wedding, Heinrich Bodenstein, Hannes Wandt, Christian Boewer, Rita Pasold, Hans-Heinrich Wolf, Mathias Hänel, Gottfried Dölken, Christian Junghanss, Reinhard Andreesen and Hartmut Bertz

in Journal of Antimicrobial Chemotherapy

Published on behalf of British Society for Antimicrobial Chemotherapy

Volume 57, issue 2, pages 317-325
Published in print February 2006 | ISSN: 0305-7453
Published online December 2005 | e-ISSN: 1460-2091 | DOI: http://dx.doi.org/10.1093/jac/dki440
An open-label randomized trial comparing itraconazole oral solution with fluconazole oral solution for primary prophylaxis of fungal infections in patients with haematological malignancy and profound neutropenia

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Objectives: This trial studied the efficacy and safety of itraconazole and fluconazole in the prevention of invasive fungal infections in neutropenic patients with haematological malignancies.

Patients and methods: An 8 week, open-label, randomized, parallel-group, multicentre trial comparing itraconazole oral solution (2.5 mg/kg twice daily; N = 248) with fluconazole oral solution or capsules (400 mg daily; N = 246) in 494 patients with anticipated profound neutropenia (i.e. neutrophil count expected to be <500 cells/mm3 for at least 10 days) from tertiary care centres.

Results: Invasive fungal infections were reported for 4 out of 248 patients (1.6%) in the itraconazole group and 5 out of 246 patients (2.0%) in the fluconazole group. Invasive Aspergillus infections were proven for 2 out of 248 patients (0.8%) in the itraconazole group and 3 out of 246 patients (1.2%) in the fluconazole group. For both the ITT and profoundly neutropenic populations, no differences were detected between treatment groups in proven or suspected invasive fungal infections or other endpoints. The mortality rates owing to proven invasive fungal infections were 2 out of 248 patients (0.8%) for the itraconazole group and 3 out of 246 patients (1.2%) for the fluconazole group. There was also no difference between treatment groups in the number of patients who recovered from neutropenia or in the duration of neutropenia. More discontinuation of drug intake owing to nausea and more hypokalaemia occurred in the itraconazole group, other adverse events and the total number of adverse events were similar in both groups.

Conclusions: In this study there were no differences in the efficacy and safety of itraconazole and fluconazole prophylaxis in neutropenic patients with haematological malignancies.

Keywords: invasive fungal infections; candidiasis; antifungal prophylaxis; aspergillosis; survival

Journal Article.  6721 words.  Illustrated.

Subjects: Medical Oncology ; Critical Care

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