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

Condition(s) targeted: Candidemia; Candidiasis

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

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

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

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

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

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 suspected Candida osteomyelitis, endocarditis or meningitis.

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

Pfizer Investigational Site, BESANCON Cedex 25030, France; Not yet recruiting

Pfizer Investigational Site, PARIS Cedex 12 75571, France; Not yet recruiting

Pfizer Investigational Site, PARIS 75019, France; Not yet recruiting

Pfizer Investigational Site, Thessaloniki 54642, Greece; Not yet recruiting

Pfizer Investigational Site, Athens 11527, Greece; Not yet recruiting

Pfizer Investigational Site, Pavia 27100, Italy; Not yet recruiting

Pfizer Investigational Site, Genova 16147, Italy; Not yet recruiting

Pfizer Investigational Site, Roma 00161, Italy; Not yet recruiting

Pfizer Investigational Site, Roma 00165, Italy; Not yet recruiting

Pfizer Investigational Site, Seoul 120-752, Korea, Republic of; Not yet recruiting

Pfizer Investigational Site, Lisboa 1169-045, Portugal; Not yet recruiting

Pfizer Investigational Site, Lisboa 1649-035, Portugal; Not yet recruiting

Pfizer Investigational Site, Lisboa 4200-319, Portugal; Not yet recruiting

Pfizer Investigational Site, Coimbra 3000-076, Portugal; Not yet recruiting

Pfizer Investigational Site, Porto 4200-072, Portugal; Not yet recruiting

Pfizer Investigational Site, Moscow 115478, Russian Federation; Not yet recruiting

Pfizer Investigational Site, Moscow 117997, Russian Federation; Not yet recruiting

Pfizer Investigational Site, BARCELONA 08035, Spain; Not yet recruiting

Pfizer Investigational Site, MADRID 28046, Spain; Not yet recruiting

Pfizer Investigational Site, VALENCIA 46009, Spain; Not yet recruiting

Pfizer Investigational Site, Taichung 404, Taiwan; Not yet recruiting

Pfizer Investigational Site, Edmonton, Alberta T5H 3V9, Canada; Not yet recruiting

Pfizer Investigational Site, Edmonton, Alberta T6G 2R7, Canada; Not yet recruiting

Pfizer Investigational Site, Oakland, California 94609, United States; Recruiting

Pfizer Investigational Site, Orange, California 92868, United States; Recruiting

Pfizer Investigational Site, Miami, Florida 33155, United States; Recruiting

Pfizer Investigational Site, Jacksonville, Florida 32207, United States; Not yet recruiting

Pfizer Investigational Site, Jacksonville, Florida 32209, United States; Not yet recruiting

Pfizer Investigational Site, Atlanta, Georgia 30322, United States; Recruiting

Pfizer Investigational Site, Honolulu, Hawaii 96826, United States; Recruiting

Pfizer Investigational Site, Seoul, Korea 138-736, Korea, Republic of; Recruiting

Pfizer Investigational Site, Shreveport, Louisiana 71130, United States; Not yet recruiting

Pfizer Investigational Site, New Orleans, Louisiana 70118, United States; Recruiting

Pfizer Investigational Site, New Orleans, Louisiana 70121, United States; Recruiting

Pfizer Investigational Site, Boston, Massachusetts 02111, United States; Recruiting

Pfizer Investigational Site, Jackson, Mississippi 39216, United States; Recruiting

Pfizer Investigational Site, Durham, North Carolina 27710, United States; Not yet recruiting

Pfizer Investigational Site, Cleveland, Ohio 44106, United States; Recruiting

Pfizer Investigational Site, Toronto, Ontario M5G 1X8, Canada; Not yet recruiting

Pfizer Investigational Site, London, Ontario N6A 5W9, Canada; Not yet recruiting

Pfizer Investigational Site, Kwei Shan Town, Taoyuan County 333, Taiwan; Recruiting

Pfizer Investigational Site, Memphis, Tennessee 38105, United States; Recruiting

Pfizer Investigational Site, Fort Worth, Texas 76104-2796, United States; Recruiting

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

Starting date: November 2008
Ending date: May 2010
Last updated: September 21, 2009