A8851008 study of Anidulafungin in children with Invasive Candidiasis
Research type
Research Study
Full title
A Prospective, Open-Label Study To Assess The Pharmacokinetics, Safety & Efficacy Of Anidulafungin When Used To Treat Children With Invasive Candidiasis, Including Candidemia
IRAS ID
208606
Contact name
Stephane Paulus
Contact email
Sponsor organisation
Pfizer Inc.
Duration of Study in the UK
3 years, 6 months, 9 days
Research summary
This is an open-label study of anidulafungin to assess the pharmacokinetics (how the study drug is absorbed, distributed, broken down and expelled by the body), safety and effectiveness of intravenous (IV) anidulafungin when used to treat children aged 1 month to 18 years with invasive candidiasis, including candidemia (ICC). Only children under the age of 5 are being recruited in the UK because the strata for children 5 to < 18 years have been filled.
About 70 participants will be involved in the study from about 50 hospitals throughout the Unites States of America, Europe, Latin America, and Asia.
Suitable participants must have had a confirmed diagnosis of ICC or strong evidence of Candida sp ((which must be confirmed within 96 hours of initiation of study drug). All suitable participants will receive IV anidulafungin. On Day 1, participants will receive a starting dose of 3.0 mg/kg. Participants will then receive a daily dose of 1.5 mg/kg from Day 2 onwards. Participants may
be switched to oral fluconazole (6-12 mg/kg/day, maximum 800 mg/day) after at least 10 days of IV treatment as deemed appropriate by the study doctor.The maximum total treatment duration in this study is 49 days and the maximum allowed treatment duration with anidulafungin is 35 days.
The following are some of the study procedures that will be performed during study visits: blood tests, specimen cultures, eye examination and physical examination.
It is hoped the results of this study will help to develop effective treatment for children with invasive candidiasis, including candidemia.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0495
Date of REC Opinion
18 Aug 2016
REC opinion
Further Information Favourable Opinion