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

NCT00761267

Last updated date
Study Location
Miller Children's Hospital Bickerstaff Pediatric Family Center
Long Beach, California, 90806, United States
Contact
1-800-718-1021
ClinicalTria[email protected]

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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 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
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 < 3 days.


- Patients with documented or suspected Candida meningitis.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
Official Title  ICMJE A PROSPECTIVE, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY & EFFICACY OF ANIDULAFUNGIN WHEN USED TO TREAT CHILDREN WITH INVASIVE CANDIDIASIS, INCLUDING CANDIDEMIA
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 candidemia (ICC).
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Candidemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Anidulafungin IV
All subjects meeting screening criteria will receive IV anidulafungin.
Interventions:
  • Drug: Anidulafungin
  • Drug: Fluconazole
Publications * Roilides E, Carlesse F, Leister-Tebbe H, Conte U, Yan JL, Liu P, Tawadrous M, Aram JA, Queiroz-Telles F; Anidulafungin A8851008 Pediatric Study Group. A Prospective, Open-label Study to Assess the Safety, Tolerability and Efficacy of Anidulafungin in the Treatment of Invasive Candidiasis in Children 2 to <18 Years of Age. Pediatr Infect Dis J. 2019 Mar;38(3):275-279. doi: 10.1097/INF.0000000000002237.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2018)
70
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2008)
60
Actual Study Completion Date  ICMJE February 2018
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 1 Month to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Canada,   Greece,   Italy,   Korea, Republic of,   Russian Federation,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries France,   Germany,   Portugal
 
Administrative Information
NCT Number  ICMJE NCT00761267
Other Study ID Numbers  ICMJE A8851008
2008-004150-32 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP