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Study To Assess Pharmacokinet...

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

Last Updated: 2019-04-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2018-02-28

Brief Summary

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Detailed Description

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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

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Candidemia

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anidulafungin IV

All subjects meeting screening criteria will receive IV anidulafungin.

Group Type EXPERIMENTAL

Anidulafungin

Intervention Type DRUG

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.

Fluconazole

Intervention Type DRUG

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.

Interventions

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Anidulafungin

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Eraxis Diflucan

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Miller Children's Hospital Bickerstaff Pediatric Family Center

Long Beach, California, United States

Site Status

University of California - Los Angeles

Los Angeles, California, United States

Site Status

University of California - Los Angeles - Ronald Reagan Medical Center

Los Angeles, California, United States

Site Status

University of California - Los Angeles - Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status

Children's Hospital & Research Center Oakland (CHRCO)

Oakland, California, United States

Site Status

Children's Hospital of Orange County - Inpatient Pharmacy

Orange, California, United States

Site Status

Children's Hospital of Orange County

Orange, California, United States

Site Status

Miami Children's Hospital

Miami, Florida, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status