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Study To Assess The Safety, Pharmacokinetics, And Evaluate The Response To Anidulafungin When Treating Children With Invasive Candidiasis

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Candidemia

Intervention: anidulafungin (Drug); fluconazole (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Summary

Anidulafungin (an antifungal drug) is relatively safe and the benefits outweigh the potential adverse effects when used in children diagnosed with invasive candidiasis, including candidemia.

Clinical Details

Official title: A Prospective, Open-label Study To Assess The Pharmacokinetics, Safety & Efficacy Of Anidulafungin When Used To Treat Children With Invasive Candidiasis, Including Candidemia

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To assess the safety and tolerability of anidulafungin when used to treat children with invasive candidiasis, including candidemia.

Secondary outcome:

To assess rates of relapse at the Week 2 and Week 6 FU visits

To assess all-cause mortality at the EOIVT and EOT time points

To explore pharmacokinetic parameters of anidulafungin in children aged 1 month to <2 years following IV infusion of anidulafungin (area under curve over dosing interval (AUC24) and peak concentration (Cmax));

To assess the efficacy of anidulafungin, as measured by global response, at the following time points: EOIVT, EOT, 2-week FU visit and 6-week FU visit

To explore the exposure-response (safety and efficacy endpoints) relationship of anidulafungin using a nonlinear mixed effects approach as appropriate, including exploring the association between PK-PD index (eg, AUC/MIC) and efficacy endpoints;

To assess rates of emerging infection at the Week 2 and Week 6 FU visits

Eligibility

Minimum age: 1 Month. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female patients from 1 month to less than 18 years of age.

- Diagnosed with invasive candidiasis including candidemia.

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 prosthetic devices or heart valves suspected to be the source of

infection and can not be removed.

- Patients with documented or suspected Candida meningitis.

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Aghia Sophia Childrens Hospital, Athens 11527, Greece; Active, not recruiting

Hipokration Hospital, 3rd Department of Paediatrics, Thessaloniki 54642, Greece; Recruiting

Ematologia Oncologia Pediatrica, Universita di Pavia, Pavia 27100, Italy; Not yet recruiting

Dipartimento di Biotecnologie Cellulari ed Ematologia, Roma 00161, Italy; Recruiting

Severance Hospital, Yonsei University Health System, Seoul 120-752, Korea, Republic of; Active, not recruiting

Fed. Scientific Center for Pediatric Hematology, Oncology and Immunology of Russian Healthcare Org., Moscow 117997, Russian Federation; Terminated

National Cancer Research Center RAMS, Laboratory Microbiological Diagnostics, Moscow 115478, Russian Federation; Recruiting

Hospital Vall D'Hebron, Barcelona 08035, Spain; Active, not recruiting

China Medical University Hospital, Taichung 404, Taiwan; Recruiting

Chang Gung Medical Foundation-Linkou Branch, Taoyuan County 333, Taiwan; Recruiting

Chang Gung medical foundation-LINKOU BRANCH, Clinical Research Pharmacy, Taoyuan Hsien 333, Taiwan; Recruiting

Stollery Children's Hospital - University of Alberta, Edmonton, Alberta T6G 2R7, Canada; Active, not recruiting

Miller Children's Hospital Bickerstaff Pediatric Family Center, Long Beach, California 90806, United States; Active, not recruiting

University of California - Los Angeles, Los Angeles, California 90095-1752, United States; Recruiting

University of California - Los Angeles - Ronald Reagan UCLA Medical Center, Los Angeles, California 90095, United States; Recruiting

University of California - Los Angeles - Ronald Regan Medical Center, Los Angeles, California 90095, United States; Recruiting

Children's Hospital & Research Center Oakland (CHRCO), Oakland, California 94609, United States; Active, not recruiting

Children's Hospital of Orange Country, Orange, California 92868, United States; Active, not recruiting

Miami Children's Hospital, Miami, Florida 33155, United States; Terminated

Chang Gung Medical Foundation-Linkou Branch, Clinical Research Pharmacy, Taoyuan, Kweishan 333, Taiwan; Recruiting

University of Mississippi, Jackson, Mississippi 39216, United States; Recruiting

Duke University Medical Center, Durham, North Carolina 27710, United States; Terminated

University Hospitals Case Medical Center, Cleveland, Ohio 44106-5199, United States; Recruiting

University Hospitals of Cleveland Laboratory University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States; Active, not recruiting

Hospital Pequeno Principe, Curitiba, PR 80250-060, Brazil; Recruiting

Hospital de Clinicas da Universidade Federal do Parana, Curitiba, Paraná 80060-900, Brazil; Recruiting

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15224, United States; Recruiting

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania 15224, United States; Recruiting

Instituto de Oncologia Pediátrica - Grupo de Apoio ao Adolescente e a Criança com Câncer, Sao Paulo, SP 04023-062, Brazil; Recruiting

Instituto de Oncologia Pediátrica - Grupo de Apoio ao Adolescente e a Criança com Câncer, São Paulo, SP 04023-062, Brazil; Recruiting

Asan Medical Center, Songpa-gu, Seoul 138-736, Korea, Republic of; Active, not recruiting

Chang Gung Children's Hospital, Kwei Shan Town, Taoyuan County 333, Taiwan; Recruiting

Le Bonheur Children's Hospital - 4th Floor, Memphis, Tennessee 38103, United States; Active, not recruiting

Le Bonheur Children's Hospital - 7th Floor lab, Memphis, Tennessee 38103, United States; Active, not recruiting

LeBonheur Children's Hospital, Memphis, Tennessee 38103, United States; Active, not recruiting

LeBonheur Children's Hospital- Central Laboratory, Memphis, Tennessee 38103, United States; Active, not recruiting

Pediatric Clinical Research Unit University of Tennessee Health Science Center, Memphis, Tennessee 38103, United States; Active, not recruiting

Pediatric Clinical Research Unit- 7th Floor Lab, Memphis, Tennessee 38103, United States; Active, not recruiting

Pharmacy-University of Tennessee Health Science Center, Memphis, Tennessee 38103, United States; Active, not recruiting

University of Tennessee Health Science Center, Memphis, Tennessee 38105, United States; Active, not recruiting

University of Tennessee Health Science Center, Department of Ophthalmology, Memphis, Tennessee 38163, United States; Active, not recruiting

University of Tennessee Medical Group Pediatrics, Memphis, Tennessee 38105, United States; Active, not recruiting

Cook Children's Infectious Diseases Clinic, Fort Worth, Texas 76104, United States; Active, not recruiting

Cook Children's Medical Center, Fort Worth, Texas 76104, United States; Active, not recruiting

Infectious Diseases Clinic Cook Children's Medical Center, Fort Worth, Texas 76104, United States; Active, not recruiting

Children's Hospital of Wisconsin, Milwaukee, Wisconsin 53226, United States; Recruiting

Children's Hospital of Wisconsin (Research Pharmacy), Milwaukee, Wisconsin 53201-1997, United States; Recruiting

Children's Hospital of Wisconsin Logistics Warehouse, West Allis, Wisconsin 53214, United States; Recruiting

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: February 2009
Last updated: August 5, 2015

Page last updated: August 20, 2015

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