Status:
COMPLETED
Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
Lead Sponsor:
Pfizer
Conditions:
Candidemia
Eligibility:
All Genders
1-17 years
Phase:
PHASE3
Brief 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 candidemi...
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 candidem...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00761267
Start Date
February 1 2009
End Date
February 1 2018
Last Update
April 4 2019
Active Locations (45)
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1
Miller Children's Hospital Bickerstaff Pediatric Family Center
Long Beach, California, United States, 90806
2
University of California - Los Angeles
Los Angeles, California, United States, 90095-1752
3
University of California - Los Angeles - Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
4
University of California - Los Angeles - Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095