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Liposomales Amphotericin B zur Prophylaxe invasiver Pilzinfektionen bei pädiatrischen Hochrisikopatienten mit chemotherapieinduzierter Granulozytopenie: Interimsanalyse einer prospektiven Studie
Author(s) -
Uhlenbrock S.,
Zimmermann M.,
Fegeler W.,
Jürgens H.,
Ritter J.
Publication year - 2001
Publication title -
mycoses
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.13
H-Index - 69
eISSN - 1439-0507
pISSN - 0933-7407
DOI - 10.1046/j.1439-0507.2001.00706.x
Subject(s) - medicine , neutropenia , interim analysis , incidence (geometry) , amphotericin b , clinical endpoint , chemotherapy , mycosis , prospective cohort study , surgery , antifungal , clinical trial , physics , dermatology , optics
Summary. Invasive fungal infections (IFI) are a major cause of morbidity and mortality in patients with cancer. A retrospective analysis of children with cancer at high risk for IFI treated at Mu¨nster University Hospital showed that the incidence (7.4% vs. 1.8%) and lethality (28.1% vs. 0) of documented IFI were lower in patients receiving systemic antifungal prophylaxis with liposomal amphotericin B (l‐AmB) in comparison to a historical control group. To determine whether this decline in incidence and lethality was due to antifungal prophylaxis or was produced by advances in diagnostic procedures and early empirical antifungal therapy, a prospective study was initiated. Patients in the prophylaxis arm received thrice‐weekly 1 mg kg −1 body weight 1‐AmB, whilst patients in the early intervention arm received no prophylaxis. Diagnostic procedures and antifungal therapy for suspected or proven IFI were initiated as clinically indicated for all patients. The primary endpoint of the study was the incidence of IFI. Secondary endpoints were the use of therapeutic doses of l‐AmB, the safety of prophylactic l‐AmB, and the total consumption of l‐AmB for antifungal therapy. The interim analysis after 1 year showed no differences between the two approaches with respect to the incidence of IFI and to safety issues.