NCT00761267

Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis

A PROSPECTIVE, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY & EFFICACY OF ANIDULAFUNGIN WHEN USED TO TREAT CHILDREN WITH INVASIVE CANDIDIASIS, INCLUDING CANDIDEMIA

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

Summary

Prospective, open label study to assess the pharmacokinetics, safety \& efficacy of anidulafungin when used to treat children (aged 1 month - \<18 years) with invasive candidiasis, including candidemia (ICC).

Detailed description

Prospective, open label study to assess the pharmacokinetics, safety \& efficacy of anidulafungin when used to treat children (aged 1 month - \< 18 years) with invasive candidiasis, including candidemia (ICC). To participate in the study, at the time of enrollment subjects must (1) have either a confirmed diagnosis of ICC or mycological evidence highly suggestive of Candida sp or (2) in infants 1 month to \< 2 years only, be at high risk of candidiasis. All subjects meeting screening criteria receive IV anidulafungin. Subjects will be stratified by age (1 month - \< 2 years; 2 years - \< 5 years; 5 years - \< 18 years). Subjects may be switched to oral fluconazole, provided that the pre-specified criteria are met. Subjects with microbiologically confirmed ICC must have a minimum total treatment duration of 14 days. The maximum allowed treatment duration of anidulafungin is 35 days; the maximum total treatment duration for the study is 49 days. At selected centers, anidulafungin pharmacokinetics will be assessed in the first 6 subjects age 1 month - \< 2 years to confirm the recommended dosage regimen. A population PK-PD analysis will be performed in all other enrolled subjects. Subjects will be followed for safety through 6 week FU visit. Efficacy for subjects with confirmed ICC will be assessed at EOIVT, EOT, 2-week FU and 6-week FU visits.

Conditions

• Candidemia

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2009-02-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2008-09-29
• Last updated: 2019-04-04
• Results posted: 2018-09-14

Locations

45 sites across 10 countries: United States, Brazil, Canada, Greece, Italy, Russia, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study