title: 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.
abstract: OBJECTIVE
  This trial studied the efficacy and safety of itraconazole and fluconazole in the prevention of invasive fungal infections in neutropenic patients with haematological malignancies.
  
  
  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.
authors.affiliation: Department of Internal Medicine I, University of Bonn, Bonn, Germany. glasmacher@uni-bonn.de
authors.forename: Axel
authors.initials: A
authors.lastname: Glasmacher
authors.forename: Oliver
authors.initials: O
authors.lastname: Cornely
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Ullmann
authors.forename: Ulrich
authors.initials: U
authors.lastname: Wedding
authors.forename: Heinrich
authors.initials: H
authors.lastname: Bodenstein
authors.forename: Hannes
authors.initials: H
authors.lastname: Wandt
authors.forename: Christian
authors.initials: C
authors.lastname: Boewer
authors.forename: Rita
authors.initials: R
authors.lastname: Pasold
authors.forename: Hans-Heinrich
authors.initials: HH
authors.lastname: Wolf
authors.forename: Mathias
authors.initials: M
authors.lastname: Hänel
authors.forename: Gottfried
authors.initials: G
authors.lastname: Dölken
authors.forename: Christian
authors.initials: C
authors.lastname: Junghanss
authors.forename: Reinhard
authors.initials: R
authors.lastname: Andreesen
authors.forename: Hartmut
authors.initials: H
authors.lastname: Bertz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001228:Aspergillosis / Q000382:microbiology / Q000401:mortality / Q000517:prevention & control; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D015725:Fluconazole / Q000008:administration & dosage / Q000627:therapeutic use*; D019337:Hematologic Neoplasms / Q000150:complications*; D006801:Humans; D017964:Itraconazole / Q000008:administration & dosage / Q000627:therapeutic use*; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000150:complications / Q000517:prevention & control*; D009503:Neutropenia / Q000150:complications*; D009504:Neutrophils
chemical_list: D000935:Antifungal Agents; D017964:Itraconazole; D015725:Fluconazole