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Eligibility
for people ages 1 month to 17 years
Location
at Oakland, California and other locations
Dates
study started
estimated completion:

Description

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).

Official Title

A Prospective, Open-label Study To Assess The Pharmacokinetics, Safety & Efficacy Of Anidulafungin When Used To Treat Children With Invasive Candidiasis, Including Candidemia

Details

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.

Keywords

Candidemia Anidulafungin pediatrics invasive candidiasis safety Echinocandins Fluconazole

Eligibility

You can join if…

Open to people ages 1 month to 17 years

  • Subject must be either (1) at high risk for candidiasis (1 month - < 2 years ONLY) or(2) have a definitive diagnosis of invasive candidiasis/candidemia (ICC) (All age groups)
  • Male and female patients from 1 month to less than 18 years of age.

You CAN'T join if...

  • Any patients with allergy to the drug; and any pregnant female or lactating.
  • Failed previous antifungal therapy or expected to live < 3 days.
  • Patients with documented or suspected Candida meningitis.

Locations

  • University of California - Los Angeles accepting new patients
    Los Angeles, California, 90095-1752, United States
  • University of California - Los Angeles - Ronald Reagan Medical Center accepting new patients
    Los Angeles, California, 90095, United States
  • University of California - Los Angeles - Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles, California, 90095, United States
  • Miller Children's Hospital Bickerstaff Pediatric Family Center in progress, not accepting new patients
    Long Beach, California, 90806, United States
  • Children's Hospital of Orange County - Inpatient Pharmacy in progress, not accepting new patients
    Orange, California, 92868, United States
  • Children's Hospital of Orange County in progress, not accepting new patients
    Orange, California, 92868, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT00761267
Phase
Phase 3
Study Type
Interventional
Last Updated
May 1, 2017