title: Micafungin versus fluconazole for prophylaxis against invasive fungal infections during neutropenia in patients undergoing hematopoietic stem cell transplantation.
abstract: We hypothesized that chemoprophylaxis with the echinocandin micafungin would be an effective agent for antifungal prophylaxis during neutropenia in patients undergoing hematopoietic stem cell transplantation (HSCT). We therefore conducted a randomized, double-blind, multi-institutional, comparative phase III trial, involving 882 adult and pediatric patients, of 50 mg of micafungin (1 mg/kg for patients weighing <50 kg) and 400 mg of fluconazole (8 mg/kg for patients weighing <50 kg) administered once per day. Success was defined as the absence of suspected, proven, or probable invasive fungal infection (IFI) through the end of therapy and as the absence of proven or probable IFI through the end of the 4-week period after treatment. The overall efficacy of micafungin was superior to that of fluconazole as antifungal prophylaxis during the neutropenic phase after HSCT (80.0% in the micafungin arm vs. 73.5% in the fluconazole arm [difference, 6.5%]; 95% confidence interval, 0.9%-12%; P=.03). This randomized trial demonstrates the efficacy of an echinocandin for antifungal prophylaxis in neutropenic patients.
authors.affiliation: University of Minnesota, Minneapolis, MN, USA.
authors.forename: Jo-Anne H
authors.initials: JA
authors.lastname: van Burik
authors.forename: Voravit
authors.initials: V
authors.lastname: Ratanatharathorn
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Stepan
authors.forename: Carole B
authors.initials: CB
authors.lastname: Miller
authors.forename: Jeffrey H
authors.initials: JH
authors.lastname: Lipton
authors.forename: David H
authors.initials: DH
authors.lastname: Vesole
authors.forename: Nancy
authors.initials: N
authors.lastname: Bunin
authors.forename: Donna A
authors.initials: DA
authors.lastname: Wall
authors.forename: John W
authors.initials: JW
authors.lastname: Hiemenz
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Satoi
authors.forename: Jeanette M
authors.initials: JM
authors.lastname: Lee
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Walsh
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D054714:Echinocandins; D005260:Female; D015725:Fluconazole / Q000627:therapeutic use*; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006801:Humans; D007223:Infant; D055666:Lipopeptides; D008074:Lipoproteins / Q000627:therapeutic use*; D008297:Male; D000077551:Micafungin; D008875:Middle Aged; D009181:Mycoses / Q000209:etiology* / Q000517:prevention & control*; D009503:Neutropenia / Q000150:complications*; D010456:Peptides, Cyclic / Q000627:therapeutic use*
chemical_list: D054714:Echinocandins; D055666:Lipopeptides; D008074:Lipoproteins; D010456:Peptides, Cyclic; D015725:Fluconazole; D000077551:Micafungin