JAC Advance Access originally published online on December 8, 2005
Journal of Antimicrobial Chemotherapy 2006 57(2):317-325; doi:10.1093/jac/dki440
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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
1 Department of Internal Medicine I, University of Bonn, Bonn, Germany; 2 Department of Internal Medicine I, University of Cologne, Cologne, Germany; 3 Department of Internal Medicine III, University of Mainz, Mainz, Germany; 4 Department of Internal Medicine II, University of Jena, Jena, Germany; 5 Department of Haematology and Oncology, Klinikum Minden, Minden, Germany; 6 Department of Internal Medicine V, Klinikum Nürnberg (Nord), Nürnberg, Germany; 7 Department of Internal Medicine, St Hedwig Hospital, Berlin, Germany; 8 Department of Haematology and Oncology, Klinikum Ernst von Bergmann, Potsdam, Germany; 9 Department of Internal Medicine IV, University of Halle, Halle/Saale, Germany; 10 Department of Internal Medicine III (Küchwald Hospital), Klinikum Chemnitz, Chemnitz, Germany; 11 Department of Internal Medicine C, University of Greifswald, Greifswald, Germany; 12 Department of Internal Medicine, Haematology and Oncology, University of Rostock, Rostock, Germany; 13 Department of Haematology and Oncology, University of Regensburg, Regensburg, Germany; 14 Department of Internal Medicine, University of Freiburg, Freiburg, Germany
Received 6 February 2005; returned 13 April 2005; revised 28 October 2005; accepted 7 November 2005
* Corresponding author. Tel: +49-228-287-5507; Fax: +49-228-287-5849; E-mail: glasmacher{at}uni-bonn.de
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
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