1942
document
A randomized controlled trial of itraconazole versus fluconazole for the prevention of fungal infections in patients with haematological malignancies . U.K. Multicentre Antifungal Prophylaxis Study Group . Fluconazole is widely used as antifungal prophylaxis but it is ineffective against Aspergillus . Itraconazole has a broader spectrum of activity but the capsules give erratic bioavailability in neutropenic patients . We compared itraconazole oral solution ( which has an improved pharmacokinetic profile ) with fluconazole for antifungal prophylaxis . Adults with haematological malignancies receiving chemotherapy or bone marrow transplants were randomly allocated 5 mg/kg/d itraconazole ( itra ) solution ( 288 episodes ) or 100 mg fluconazole suspension ( flu ) ( 293 episodes ) from before the onset of neutropenia until neutrophil recovery or suspected fungal infection . Outcomes were assessed by independent reviewers unaware of the prophylaxis allocation . More proven systemic fungal infections occurred in flu ( Aspergillus four , Candida tropicalis one , C. krusei one ) than itra ( C. albicans one ) and more of these were fatal ( four versus nil ) . This difference reached statistical significance when first study episodes were considered separately ( six flu versus nil itra , P = 0.03 ) . Significantly more deaths of presumed fungal origin occurred in flu than itra ( seven versus nil , P = 0.024 ) . There were significantly more cases of proven aspergillosis in flu than itra ( six versus nil , P = 0.038 , 5/6 cases were fatal ) if those occurring outside the study period are included . Significantly more patients receiving flu required amphotericin B ( 58 v 39 , P = 0.043 ) but this may have been affected by the fact that the study was not blinded . There were 11 proven mucosal candidal infections in flu and four in itra . Itraconazole solution and fluconazole provide effective prophylaxis against Candida but itraconazole affords greater protection against fatal aspergillosis .
1943
Intervention_Pharmacological
itraconazole
1944
Intervention_Pharmacological
fluconazole
1945
Intervention_Pharmacological
Fluconazole
1946
Intervention_Pharmacological
Itraconazole
1947
Intervention_Pharmacological
itraconazole oral solution
1948
Intervention_Pharmacological
fluconazole
1949
Intervention_Pharmacological
itraconazole ( itra )
1950
Intervention_Pharmacological
fluconazole suspension ( flu )
1951
Intervention_Pharmacological
Itraconazole
1952
Intervention_Pharmacological
fluconazole
1953
Outcome_Physical
prevention of fungal infections
1954
Outcome_Physical
antifungal prophylaxis
1955
Outcome_Physical
proven systemic fungal infections
1956
Outcome_Mortality
deaths of presumed fungal origin
1957
Outcome_Physical
aspergillosis
1958
Outcome_Physical
mucosal candidal infections
1959
Outcome_Mortality
aspergillosis .
1960
Participant_Condition
haematological malignancies
1961
Participant_Age
Adults