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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00761267
First received: September 25, 2008
Last updated: February 9, 2017
Last verified: February 2017
  Purpose
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).

Condition Intervention Phase
Candidemia
Drug: Anidulafungin
Drug: Fluconazole
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To assess the safety and tolerability of anidulafungin when used to treat children with invasive candidiasis, including candidemia. [ Time Frame: Duration of the trial ]

Secondary Outcome Measures:
  • To assess rates of relapse at the Week 2 and Week 6 FU visits [ Time Frame: Week 2 and Week 6 FU visits ]
  • To assess all-cause mortality during study therapy and follow-up visits [ Time Frame: EOIVT, EOT, Week 2 and Week 6 FU visits ]
  • 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)); [ Time Frame: Day 1 - Day 2 ]
  • 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 [ Time Frame: EOIVT, EOT, Week 2 and Week 6 FU visits ]
  • 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; [ Time Frame: Day 1 - Day 9, at specified collection time points ]
  • To assess rates of new infection at the Week 2 and Week 6 FU visits [ Time Frame: Week 2 and Week 6 FU visits ]
  • • To explore pharmacokinetic parameters of polysorbate 80 following IV infusion of anidulafungin (AUC24 and Cmax) [ Time Frame: Day 1 - Day 9, at specified collection times ]

Estimated Enrollment: 60
Study Start Date: February 2009
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anidulafungin IV
All subjects meeting screening criteria will receive IV anidulafungin.
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

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.
  Eligibility

Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761267

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, California
Miller Children's Hospital Bickerstaff Pediatric Family Center Active, not recruiting
Long Beach, California, United States, 90806
University of California - Los Angeles Recruiting
Los Angeles, California, United States, 90095-1752
University of California - Los Angeles - Ronald Reagan Medical Center Recruiting
Los Angeles, California, United States, 90095
University of California - Los Angeles - Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Children's Hospital & Research Center Oakland (CHRCO) Active, not recruiting
Oakland, California, United States, 94609
Children's Hospital of Orange County - Inpatient Pharmacy Active, not recruiting
Orange, California, United States, 92868
Children's Hospital of Orange County Active, not recruiting
Orange, California, United States, 92868
United States, Connecticut
Connecticut Children's Medical Center Not yet recruiting
Hartford, Connecticut, United States, 06106
United States, Florida
Miami Children's Hospital Terminated
Miami, Florida, United States, 33155
United States, Missouri
Children's Mercy Hospitals & Clinics Not yet recruiting
Kansas City, Missouri, United States, 64108
United States, North Carolina
Duke University Medical Center Terminated
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106-5199
University Hospitals of Cleveland Laboratory University Hospitals Case Medical Center Active, not recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Le Bonheur Children's Hospital - 4th Floor Active, not recruiting
Memphis, Tennessee, United States, 38103
Le Bonheur Children's Hospital - 7th Floor lab Active, not recruiting
Memphis, Tennessee, United States, 38103
LeBonheur Children's Hospital- Central Laboratory Active, not recruiting
Memphis, Tennessee, United States, 38103
LeBonheur Children's Hospital Active, not recruiting
Memphis, Tennessee, United States, 38103
Pediatric Clinical Research Unit University of Tennessee Health Science Center Active, not recruiting
Memphis, Tennessee, United States, 38103
Pediatric Clinical Research Unit- 7th Floor Lab Active, not recruiting
Memphis, Tennessee, United States, 38103
Pharmacy-University of Tennessee Health Science Center Active, not recruiting
Memphis, Tennessee, United States, 38103
University of Tennessee Health Science Center Active, not recruiting
Memphis, Tennessee, United States, 38105
University of Tennessee Medical Group Pediatrics Active, not recruiting
Memphis, Tennessee, United States, 38105
University of Tennessee Health Science Center, Department of Ophthalmology Active, not recruiting
Memphis, Tennessee, United States, 38163
United States, Texas
Cook Children's Infectious Diseases Clinic Active, not recruiting
Fort Worth, Texas, United States, 76104
Cook Children's Medical Center Active, not recruiting
Fort Worth, Texas, United States, 76104
Infectious Diseases Clinic Cook Children's Medical Center Active, not recruiting
Fort Worth, Texas, United States, 76104
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Brazil
Hospital de Clinicas da Universidade Federal do Parana Recruiting
Curitiba, Paraná, Brazil, 80060-900
Hospital Pequeno Principe Recruiting
Curitiba, PR, Brazil, 80250-060
Instituto de Oncologia Pediatrica - Grupo de Apoio ao Adolescente e a Crianca com Cancer Recruiting
Sao Paulo, SP, Brazil, 04039-001
Instituto de Oncologia Pediatrica - Grupo de Apoio ao Adolescente e a Crianca com Cancer Recruiting
Sao Paulo, Brazil, 04023-062
Canada, Alberta
Stollery Children's Hospital - University of Alberta Active, not recruiting
Edmonton, Alberta, Canada, T6G 2R7
Greece
Aghia Sophia Childrens Hospital Active, not recruiting
Athens, Greece, 11527
General Children's Hospital Not yet recruiting
Athens, Greece, 11527
Hipokration Hospital, 3rd Department of Paediatrics Recruiting
Thessaloniki, Greece, 54642
Italy
Universita degli Studi di Roma La Sapienza Recruiting
Roma, Province of Rome, Italy, 00161
Ematologia Oncologia Pediatrica, Universita di Pavia Not yet recruiting
Pavia, Italy, 27100
Dipartimento di Biotecnologie Cellulari ed Ematologia Recruiting
Roma, Italy, 00161
Universitario Ospedaliero IRCCS Ospedale Pediatrico Bambino Gesu Not yet recruiting
Rome, Italy, 00165
Korea, Republic of
Asan Medical Center Active, not recruiting
Songpa-gu, Seoul, Korea, Republic of, 138-736
Severance Hospital, Yonsei University Health System Active, not recruiting
Seoul, Korea, Republic of, 120-752
Russian Federation
State Medical Institution "Children Republican Clinical Hospital" Not yet recruiting
Kazan, Tatarstan Republic, Russian Federation, 420138
National Cancer Research Center RAMS, Laboratory Microbiological Diagnostics Recruiting
Moscow, Russian Federation, 115478
Fed. Scientific Center for Pediatric Hematology, Oncology and Immunology of Russian Healthcare Org. Terminated
Moscow, Russian Federation, 117997
Spain
Hospital Vall D'Hebron Active, not recruiting
Barcelona, Spain, 08035
Taiwan
Chang Gung Children's Hospital Active, not recruiting
Kwei Shan Town, Taoyuan County, Taiwan, 333
China Medical University Hospital Active, not recruiting
Taichung, Taiwan, 404
United Kingdom
Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC) Campus - The Nottingham Chi Not yet recruiting
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Royal Hospital For Sick Children Not yet recruiting
Edinburgh, UK, United Kingdom, EH9 1LF
Clinical Microbiology, Nottingham University Hospitals NHS Trust Not yet recruiting
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00761267     History of Changes
Other Study ID Numbers: A8851008  2008-004150-32 
Study First Received: September 25, 2008
Last Updated: February 9, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Pfizer:
Anidulafungin
pediatrics
candidemia
invasive candidiasis
safety

Additional relevant MeSH terms:
Candidiasis
Candidemia
Candidiasis, Invasive
Mycoses
Fungemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Fluconazole
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors

ClinicalTrials.gov processed this record on February 24, 2017