Open AccessA Phase 3 Study of Micafungin Versus Amphotericin B Deoxycholate in Infants With Invasive Candidiasis
Author(s) -
Daniel K. Benjamin,
David Kaufman,
William Hope,
P. Brian Smith,
Antonio Arrieta,
Paolo Manzoni,
Laura Kovanda,
Christopher Lademacher,
Brigit Isaacson,
Deborah Jednachowski,
Chunzhang Wu,
Atsunori Kaibara,
Thomas J. Walsh
Publication year - 2018
Publication title -
the pediatric infectious disease journal/the pediatric infectious disease journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.028
H-Index - 140
eISSN - 1532-0987
pISSN - 0891-3668
DOI - 10.1097/inf.0000000000001996
Subject(s) - medicine , pharmacokinetics , pharmacodynamics , micafungin , clinical endpoint , confidence interval , gastroenterology , adverse effect , population , area under the curve , amphotericin b , randomized controlled trial , anesthesia , antifungal , environmental health , dermatology
Amphotericin B deoxycholate (AmB-D) is standard of care treatment for neonatal invasive candidiasis (IC). Micafungin (MCA) has broad-spectrum fungicidal activity against Candida spp. We compared the efficacy and safety of intravenous MCA with intravenous AmB-D and assessed the pharmacokinetics of MCA in infants >2-120 days of age with proven IC in a phase 3, randomized, double-blind, multicenter, parallel-group, noninferiority study (NCT00815516).