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

Completed · Phase 3

Conditions studied: Candidemia

In brief

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).

Key facts

Study ID

NCT00761267

Run by

Pfizer

People needed

70

Starts

2009-02-01

Expected to finish

2018-02-01

Last updated by the study team

2019-04-04

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Miller Children's Hospital Bickerstaff Pediatric Family Center — Long Beach, California, United States
• University of California - Los Angeles — Los Angeles, California, United States
• University of California - Los Angeles - Ronald Reagan Medical Center — Los Angeles, California, United States
• University of California - Los Angeles - Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Children's Hospital & Research Center Oakland (CHRCO) — Oakland, California, United States
• Children's Hospital of Orange County - Inpatient Pharmacy — Orange, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Miami Children's Hospital — Miami, Florida, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospitals of Cleveland Laboratory University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Le Bonheur Children's Hospital - 4th Floor — Memphis, Tennessee, United States
• Le Bonheur Children's Hospital - 7th Floor lab — Memphis, Tennessee, United States
• LeBonheur Children's Hospital- Central Laboratory — Memphis, Tennessee, United States
• LeBonheur Children's Hospital — Memphis, Tennessee, United States
• Pediatric Clinical Research Unit University of Tennessee Health Science Center — Memphis, Tennessee, United States
• Pediatric Clinical Research Unit- 7th Floor Lab — Memphis, Tennessee, United States
• Pharmacy-University of Tennessee Health Science Center — Memphis, Tennessee, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States
• University of Tennessee Medical Group Pediatrics — Memphis, Tennessee, United States
• University of Tennessee Health Science Center, Department of Ophthalmology — Memphis, Tennessee, United States
• Cook Children's Infectious Diseases Clinic — Fort Worth, Texas, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• Infectious Diseases Clinic Cook Children's Medical Center — Fort Worth, Texas, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
• Hospital de Clinicas da Universidade Federal do Parana — Curitiba, Paraná, Brazil

Full record on ClinicalTrials.gov

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