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.

2.50
Hdl Handle:
http://hdl.handle.net/10541/87892
Title:
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.
Authors:
Morgenstern, Godfrey R; Prentice, Archibald G; Prentice, H Grant; Ropner, Janet E; Schey, Stephen; Warnock, David W
Abstract:
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.
Affiliation:
Christie Hospital, Manchester.
Citation:
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. 1999, 105 (4):901-11 Br. J. Haematol.
Journal:
British Journal of Haematology
Issue Date:
Jun-1999
URI:
http://hdl.handle.net/10541/87892
DOI:
10.1046/j.1365-2141.1999.01465.x
PubMed ID:
10554799
Type:
Article
Language:
en
ISSN:
0007-1048
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorMorgenstern, Godfrey Ren
dc.contributor.authorPrentice, Archibald Gen
dc.contributor.authorPrentice, H Granten
dc.contributor.authorRopner, Janet Een
dc.contributor.authorSchey, Stephenen
dc.contributor.authorWarnock, David Wen
dc.date.accessioned2009-12-14T14:50:27Z-
dc.date.available2009-12-14T14:50:27Z-
dc.date.issued1999-06-
dc.identifier.citationA 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. 1999, 105 (4):901-11 Br. J. Haematol.en
dc.identifier.issn0007-1048-
dc.identifier.pmid10554799-
dc.identifier.doi10.1046/j.1365-2141.1999.01465.x-
dc.identifier.urihttp://hdl.handle.net/10541/87892-
dc.description.abstractFluconazole 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.en
dc.language.isoenen
dc.subjectHaematologic Canceren
dc.subject.meshAdolescent-
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAntifungal Agents-
dc.subject.meshAntineoplastic Agents, Phytogenic-
dc.subject.meshDrug Interactions-
dc.subject.meshFemale-
dc.subject.meshFluconazole-
dc.subject.meshHematologic Neoplasms-
dc.subject.meshHumans-
dc.subject.meshItraconazole-
dc.subject.meshMale-
dc.subject.meshMiddle Aged-
dc.subject.meshMycoses-
dc.subject.meshOpportunistic Infections-
dc.subject.meshVincristine-
dc.titleA 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.en
dc.typeArticleen
dc.contributor.departmentChristie Hospital, Manchester.en
dc.identifier.journalBritish Journal of Haematologyen

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