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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Information provided by (Responsible Party):
Pfizer Identifier:
First received: September 25, 2008
Last updated: September 8, 2014
Last verified: September 2014

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.

Condition Intervention Phase
Drug: anidulafungin
Drug: fluconazole
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
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 Candidaemia

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 at the EOIVT and EOT time points [ Time Frame: EOIVT and EOT ] [ 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: Initial few months of the trial ] [ 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: At the end of treatment and follow up 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: Duration of the trial ] [ Designated as safety issue: No ]
  • To assess rates of emerging infection at the Week 2 and Week 6 FU visits [ Time Frame: Week 2 and Week 6 FU visits ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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. Maximum follow up duration is 6 weeks after the end of treatment.

Other Name: Eraxis
Drug: fluconazole

Minimum IV anidulafungin treatment duration is 10 days; followed by oral fluconazole 6-12 mg/kg/day (not to exceed 800mg/day). Switch of treatment to fluconazole may only occur after:

  1. a minimum IV anidulafungin treatment of 10 days, and
  2. study specific clinical improvement criteria are met.
Other Name: Diflucan


Ages Eligible for Study:   1 Month to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT00761267

Contact: Pfizer Call Center 1-800-718-1021

  Hide Study Locations
United States, California
Pfizer Investigational Site Completed
Long Beach, California, United States, 90806
Pfizer Investigational Site Recruiting
Los Angeles, California, United States, 90095-1752
Pfizer Investigational Site Completed
Oakland, California, United States, 94609
Pfizer Investigational Site Completed
Orange, California, United States, 92868
United States, Florida
Pfizer Investigational Site Recruiting
Jacksonville, Florida, United States, 32209
Pfizer Investigational Site Terminated
Miami, Florida, United States, 33155
United States, Georgia
Pfizer Investigational Site Recruiting
Atlanta, Georgia, United States, 30322
United States, Mississippi
Pfizer Investigational Site Recruiting
Jackson, Mississippi, United States, 39216
United States, North Carolina
Pfizer Investigational Site Recruiting
Durham, North Carolina, United States, 27705
Pfizer Investigational Site Terminated
Durham, North Carolina, United States, 27710
United States, Ohio
Pfizer Investigational Site Completed
Cleveland, Ohio, United States, 44106
Pfizer Investigational Site Recruiting
Cleveland, Ohio, United States, 44106-5199
United States, Pennsylvania
Pfizer Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Pfizer Investigational Site Completed
Memphis, Tennessee, United States, 38103
Pfizer Investigational Site Completed
Memphis, Tennessee, United States, 38104
United States, Texas
Pfizer Investigational Site Completed
Fort Worth, Texas, United States, 76104
United States, Wisconsin
Pfizer Investigational Site Recruiting
Milwaukee, Wisconsin, United States, 53201-1997
Pfizer Investigational Site Recruiting
Milwaukee, Wisconsin, United States, 53226
Pfizer Investigational Site Recruiting
West Allis, Wisconsin, United States, 53214
Pfizer Investigational Site Not yet recruiting
Belo Horizonte, MG, Brazil, 30150-221
Pfizer Investigational Site Recruiting
Curitiba, Paraná, Brazil, 80060-900
Pfizer Investigational Site Recruiting
Curitiba, PR, Brazil, 80250-060
Pfizer Investigational Site Recruiting
São Paulo, SP, Brazil, 04023-062
Canada, Alberta
Pfizer Investigational Site Completed
Edmonton, Alberta, Canada, T6G 2R7
Pfizer Investigational Site Completed
Edmonton, Alberta, Canada, T5H 3V9
Canada, Ontario
Pfizer Investigational Site Recruiting
Toronto, Ontario, Canada, M5G 1X8
Pfizer Investigational Site Completed
Athens, Greece, 11527
Pfizer Investigational Site Recruiting
Thessaloniki, Greece, 54642
Pfizer Investigational Site Not yet recruiting
Pavia, Italy, 27100
Pfizer Investigational Site Recruiting
Roma, Italy, 00161
Korea, Republic of
Pfizer Investigational Site Recruiting
Songpa-gu, Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site Completed
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site Recruiting
Coimbra, Portugal, 3000-076
Pfizer Investigational Site Recruiting
Lisbon, Portugal, 1649-035
Russian Federation
Pfizer Investigational Site Recruiting
Moscow, Russian Federation, 115478
Pfizer Investigational Site Terminated
Moscow, Russian Federation, 117997
Pfizer Investigational Site Recruiting
Barcelona, Spain, 08035
Pfizer Investigational Site Recruiting
Kwei Shan Town, Taoyuan County, Taiwan, 333
Pfizer Investigational Site Recruiting
Taichung, Taiwan, 404
Pfizer Investigational Site Recruiting
Taoyuan County, Taiwan, 333
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT00761267     History of Changes
Other Study ID Numbers: A8851008
Study First Received: September 25, 2008
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
invasive candidiasis

Additional relevant MeSH terms:
Candidiasis, Invasive
Systemic Inflammatory Response Syndrome
Pathologic Processes
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 30, 2014