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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Miller Children's Hospital Bickerstaff Pediatric Family Center
Long Beach, California, 90806 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-17 month
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subject must be either (1) at high risk for candidiasis (1 month - (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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Any patients with allergy to the drug; and any pregnant female or lactating.

- Failed previous antifungal therapy or expected to live

- Patients with documented or suspected Candida meningitis.

NCT00761267
Pfizer
Completed
Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis

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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
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).
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.
Interventional
Phase 3
Masking: None (Open Label)
Primary Purpose: Treatment
Candidemia
  • 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.

    Other Name: Eraxis
  • 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.
    Other Name: Diflucan
Experimental: Anidulafungin IV
All subjects meeting screening criteria will receive IV anidulafungin.
Interventions:
  • Drug: Anidulafungin
  • Drug: Fluconazole
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 12, 2019
June 12, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
1 Month to 17 Years   (Child)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Brazil,   Canada,   Greece,   Italy,   Korea, Republic of,   Russian Federation,   Spain,   Taiwan,   United Kingdom,   United States
France,   Germany,   Portugal
 
NCT00761267
A8851008
2008-004150-32 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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