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 May 2016 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00761267
First received: September 25, 2008
Last updated: May 17, 2016
Last verified: May 2016
  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: Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • To assess all-cause mortality during study therapy and follow-up visits [ Time Frame: EOIVT, EOT, Week 2 and Week 6 FU visits ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To assess rates of new infection at the Week 2 and Week 6 FU visits [ Time Frame: Week 2 and Week 6 FU visits ] [ Designated as safety issue: Yes ]
  • • 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 ] [ Designated as safety issue: Yes ]

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. Subjects with documented or highly suspected candida infection will be initiated on therapy. Subjects enrolled on the basis of high suspicion of candida infection are required to have confirmation of candida infection within 96 hours post treatment initiation. Subjects failing to confirm within this time period may be discontinued from study treatment, but will remain in the study for safety follow-up evaluations.
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; 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:

  1. received minimum IV anidulafungin treatment of 10 days, and
  2. study specific clinical improvement criteria are met. 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 have either a confirmed diagnosis of ICC or mycological evidence highly suggestive of Candida sp. All subjects meeting screening criteria receive IV anidulafungin for a minimum of 10 days. Subjects will be stratisfied by age (1 month - < 2 years; 2 years - < 5 years; 5 years - < 18 years). Subjects may be swtiched to oral fluconazole after at least 10 days of IV anidulafungin treatment, provided that the pre-specified criteria are met. Subjects 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 assessed for safety and efficacy at EOIVT, EOT, 2-week FU and 6-week FU visits.
  Eligibility

Ages Eligible for Study:   1 Month to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 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 UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
University of California - Los Angeles - Ronald Regan Medical Center Recruiting
Los Angeles, California, United States, 90095
Children's Hospital & Research Center Oakland (CHRCO) Recruiting
Oakland, California, United States, 94609
Children's Hospital of Orange County - Inpatient Pharmacy Recruiting
Orange, California, United States, 92868
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
United States, Florida
Miami Children's Hospital Terminated
Miami, Florida, United States, 33155
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 Recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Le Bonheur Children's Hospital - 7th Floor lab Recruiting
Memphis, Tennessee, United States, 38103
University of Tennessee Health Science Center, Department of Ophthalmology Recruiting
Memphis, Tennessee, United States, 38163
LeBonheur Children's Hospital- Central Laboratory Recruiting
Memphis, Tennessee, United States, 38103
LeBonheur Children's Hospital Recruiting
Memphis, Tennessee, United States, 38103
Pediatric Clinical Research Unit University of Tennessee Health Science Center Recruiting
Memphis, Tennessee, United States, 38103
Pediatric Clinical Research Unit- 7th Floor Lab Recruiting
Memphis, Tennessee, United States, 38103
Le Bonheur Children's Hospital - 4th Floor Recruiting
Memphis, Tennessee, United States, 38103
University of Tennessee Health Science Center Recruiting
Memphis, Tennessee, United States, 38105
University of Tennessee Medical Group Pediatrics Recruiting
Memphis, Tennessee, United States, 38105
Pharmacy-University of Tennessee Health Science Center Recruiting
Memphis, Tennessee, United States, 38103
United States, Texas
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Cook Children's Infectious Diseases Clinic Recruiting
Fort Worth, Texas, United States, 76104
Infectious Diseases Clinic Cook Children's Medical Center 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 Pediátrica - Grupo de Apoio ao Adolescente e a Criança com Câncer Recruiting
Sao Paulo, SP, Brazil, 04023-062
Instituto de Oncologia Pediátrica - Grupo de Apoio ao Adolescente e a Criança com Câncer Recruiting
São Paulo, SP, Brazil, 04023-062
Canada, Alberta
Stollery Children's Hospital - University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2R7
Greece
Aghia Sophia Childrens Hospital Recruiting
Athens, Greece, 11527
Hipokration Hospital, 3rd Department of Paediatrics Recruiting
Thessaloniki, Greece, 54642
Italy
Ematologia Oncologia Pediatrica, Universita di Pavia Recruiting
Pavia, Italy, 27100
Dipartimento di Biotecnologie Cellulari ed Ematologia Recruiting
Roma, Italy, 00161
Korea, Republic of
Asan Medical Center Recruiting
Songpa-gu, Seoul, Korea, Republic of, 138-736
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 120-752
Russian Federation
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 Recruiting
Barcelona, Spain, 08035
Taiwan
Chang Gung Medical Foundation-Linkou Branch, Clinical Research Pharmacy Recruiting
Taoyuan, Kweishan, Taiwan, 333
Chang Gung Children's Hospital Recruiting
Kwei Shan Town, Taoyuan County, Taiwan, 333
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Chang Gung Medical Foundation-Linkou Branch Recruiting
Taoyuan County, Taiwan, 333
Chang Gung medical foundation-LINKOU BRANCH, Clinical Research Pharmacy Recruiting
Taoyuan Hsien, Taiwan, 333
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: May 17, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Anidulafungin
pediatrics
candidemia
invasive candidiasis
safety

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

ClinicalTrials.gov processed this record on May 26, 2016