70
Participants
Start Date
February 28, 2009
Primary Completion Date
February 28, 2018
Study Completion Date
February 28, 2018
Anidulafungin
"Day 1: loading dose of 3 mg/kg (not to exceed 200 mg) Day 2 onwards: maintain a dose of 1.5 mg/kg (not to exceed 100 mg). Minimum total treatment duration is 14 days. Minimum IV anidulafungin treatment duration is 10 days for subjects with microbiologically confirmed ICC and 5 days for subjects at risk of candidiasis; followed by oral fluconazole 6-12 mg/kg/day (not to exceed 800mg/day).~Maximum treatment duration with anidulafungin is 35 days."
Fluconazole
Subjects may be switched to oral fluconazole \[6-12 mg/kg/day (not to exceed 800mg/day\] provided they meet specified criteria. Maximum total treatment duration is 49 days.
Chang Gung Children's Hospital, Kwei Shan Town
China Medical University Hospital, Taichung
Aghia Sophia Childrens Hospital, Athens
Duke University Medical Center, Durham
Miami Children's Hospital, Miami
Le Bonheur Children's Hospital - 4th Floor, Memphis
Le Bonheur Children's Hospital - 7th Floor lab, Memphis
LeBonheur Children's Hospital- Central Laboratory, Memphis
LeBonheur Children's Hospital, Memphis
Pediatric Clinical Research Unit University of Tennessee Health Science Center, Memphis
Pediatric Clinical Research Unit- 7th Floor Lab, Memphis
Pharmacy-University of Tennessee Health Science Center, Memphis
University of Tennessee Health Science Center, Memphis
University of Tennessee Medical Group Pediatrics, Memphis
University of Tennessee Health Science Center, Department of Ophthalmology, Memphis
University Hospitals of Cleveland Laboratory University Hospitals Case Medical Center, Cleveland
Children's Hospital of Wisconsin, Milwaukee
Hippokration Hospital, Thessaloniki
Cook Children's Infectious Diseases Clinic, Fort Worth
Cook Children's Medical Center, Fort Worth
Infectious Diseases Clinic Cook Children's Medical Center, Fort Worth
University of California - Los Angeles - Ronald Reagan Medical Center, Los Angeles
University of California - Los Angeles - Ronald Reagan UCLA Medical Center, Los Angeles
Miller Children's Hospital Bickerstaff Pediatric Family Center, Long Beach
Children's Hospital of Orange County - Inpatient Pharmacy, Orange
Children's Hospital of Orange County, Orange
Children's Hospital & Research Center Oakland (CHRCO), Oakland
National Cancer Research Center RAMS n.a. N.N. Blokhin; Laboratory Microbiological Diagnostics, Moscow
Fed. Scientific Center for Pediatric Hematology, Oncology and Immunology of Russian Healthcare Org., Moscow
University of California - Los Angeles, Los Angeles
Hospital de Clinicas da Universidade Federal do Parana, Curitiba
Hospital Pequeno Principe, Curitiba
Hospital Infantil Sabara / Fundacao Jose Luiz Egydio Setubal, São Paulo
Instituto PENSI - Pesquisa e Ensino em Saúde Infantil, São Paulo
Instituto de Oncologia Pediatrica - Grupo de Apoio ao Adolescente e a Crianca com Cancer, São Paulo
Instituto de Oncologia Pediatrica - Grupo de Apoio ao Adolescente e a Crianca com Cancer, São Paulo
Stollery Children's Hospital - University of Alberta, Edmonton
Universita degli Studi di Roma La Sapienza, Roma
IRCCS Ospedale Pediatrico Bambino Gesu, Roma
Universitario Ospedaliero IRCCS Ospedale Pediatrico Bambino Gesu, Roma
Asan Medical Center, Songpa-gu
Asan Medical Center, Department of Pharmacy, Seoul
Severance Hospital, Yonsei University Health System, Seoul
Hospital Vall D'Hebron, Barcelona
Nottingham Children's Hospital, Nottingham
Lead Sponsor
Pfizer
INDUSTRY