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

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ClinicalTrials.gov Identifier: NCT00761267
Recruitment Status : Completed
First Posted : September 29, 2008
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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).

Condition or disease Intervention/treatment Phase
Candidemia Drug: Anidulafungin Drug: Fluconazole Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Masking: None (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
Actual Study Start Date : February 27, 2009
Actual Primary Completion Date : February 14, 2018
Actual Study Completion Date : February 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. To assess rates of relapse at the Week 2 and Week 6 FU visits [ Time Frame: Week 2 and Week 6 FU visits ]
  2. To assess all-cause mortality during study therapy and follow-up visits [ Time Frame: EOIVT, EOT, Week 2 and Week 6 FU visits ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. To assess rates of new infection at the Week 2 and Week 6 FU visits [ Time Frame: Week 2 and Week 6 FU visits ]
  7. • 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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761267


  Hide Study Locations
Locations
United States, California
Miller Children's Hospital Bickerstaff Pediatric Family Center
Long Beach, California, United States, 90806
University of California - Los Angeles
Los Angeles, California, United States, 90095-1752
University of California - Los Angeles - Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
University of California - Los Angeles - Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Children's Hospital & Research Center Oakland (CHRCO)
Oakland, California, United States, 94609
Children's Hospital of Orange County - Inpatient Pharmacy
Orange, California, United States, 92868
Children's Hospital of Orange County
Orange, California, United States, 92868
United States, Florida
Miami Children's Hospital
Miami, Florida, United States, 33155
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals of Cleveland Laboratory University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Tennessee
Le Bonheur Children's Hospital - 4th Floor
Memphis, Tennessee, United States, 38103
Le Bonheur Children's Hospital - 7th Floor lab
Memphis, Tennessee, United States, 38103
LeBonheur Children's Hospital- Central Laboratory
Memphis, Tennessee, United States, 38103
LeBonheur Children's Hospital
Memphis, Tennessee, United States, 38103
Pediatric Clinical Research Unit University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38103
Pediatric Clinical Research Unit- 7th Floor Lab
Memphis, Tennessee, United States, 38103
Pharmacy-University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38103
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38105
University of Tennessee Medical Group Pediatrics
Memphis, Tennessee, United States, 38105
University of Tennessee Health Science Center, Department of Ophthalmology
Memphis, Tennessee, United States, 38163
United States, Texas
Cook Children's Infectious Diseases Clinic
Fort Worth, Texas, United States, 76104
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Infectious Diseases Clinic Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Brazil
Hospital de Clinicas da Universidade Federal do Parana
Curitiba, Paraná, Brazil, 80060-900
Hospital Pequeno Principe
Curitiba, PR, Brazil, 80250-060
Hospital Infantil Sabara / Fundacao Jose Luiz Egydio Setubal
Sao Paulo, SP, Brazil, 01227-200
Instituto PENSI - Pesquisa e Ensino em Saúde Infantil
Sao Paulo, SP, Brazil, 01227-200
Instituto de Oncologia Pediatrica - Grupo de Apoio ao Adolescente e a Crianca com Cancer
Sao Paulo, SP, Brazil, 04039-001
Instituto de Oncologia Pediatrica - Grupo de Apoio ao Adolescente e a Crianca com Cancer
Sao Paulo, Brazil, 04023-062
Canada, Alberta
Stollery Children's Hospital - University of Alberta
Edmonton, Alberta, Canada, T6G 2R7
Greece
Aghia Sophia Childrens Hospital
Athens, Greece, 11527
Hippokration Hospital
Thessaloniki, Greece, 54642
Italy
Universita degli Studi di Roma La Sapienza
Roma, Province OF ROME, Italy, 00161
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, RM, Italy, 00165
Universitario Ospedaliero IRCCS Ospedale Pediatrico Bambino Gesu
Roma, RM, Italy, 00165
Korea, Republic of
Asan Medical Center
Songpa-gu, Seoul, Korea, Republic of, 138-736
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Asan Medical Center, Department of Pharmacy
Seoul, Korea, Republic of, 138-736
Russian Federation
National Cancer Research Center RAMS n.a. N.N. Blokhin; Laboratory Microbiological Diagnostics
Moscow, Russian Federation, 115478
Fed. Scientific Center for Pediatric Hematology, Oncology and Immunology of Russian Healthcare Org.
Moscow, Russian Federation, 117997
Spain
Hospital Vall D'Hebron
Barcelona, Spain, 08035
Taiwan
Chang Gung Children's Hospital
Kwei Shan Town, Taoyuan County, Taiwan, 333
China Medical University Hospital
Taichung, Taiwan, 404
United Kingdom
Nottingham Children's Hospital
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00761267     History of Changes
Other Study ID Numbers: A8851008
2008-004150-32 ( EudraCT Number )
First Posted: September 29, 2008    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Anidulafungin
pediatrics
candidemia
invasive candidiasis
safety

Additional relevant MeSH terms:
Candidiasis
Candidemia
Candidiasis, Invasive
Mycoses
Fungemia
Sepsis
Infection
Invasive Fungal Infections
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