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A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children

This study has been terminated.
(This protocol terminated prematurely on July 8, 2013 due to slow enrollment, not because of any safety issues or concerns.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00836875
First received: February 3, 2009
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to evaluate the safety profile of voriconazole (an antifungal drug) when used in children who have invasive aspergillosis (IA) and other rare systemic fungal infections.


Condition Intervention Phase
Invasive Aspergillosis
Drug: Voriconazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Open-Label, Non-Randomized, Multi-Center Study To Investigate The Safety And Tolerability Of Voriconazole As Primary Therapy For Treatment Of Invasive Aspergillosis And Molds Such As Scedosporium Or Fusarium Species In Pediatric Patients

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of Participants With a Global Response of Success [ Time Frame: Weeks 6 and End of Treatment (EOT; up to Week 12) ] [ Designated as safety issue: No ]
    Percentage of participants with global response of success at Weeks 6 and at EOT (up to Week 12). Global response of success was defined as a participant who achieved a complete or partial global response per the investigator. Complete response was defined as resolution of all clinical signs and symptoms PLUS resolution of 90 percent (%) or more of the lesions visible on radiological studies and attributed to invasive aspergillosis (IA) at Baseline. Partial response was defined as clinical improvement PLUS 50% to <90% resolution of the radiological lesions attributed to IA at Baseline.

  • All-Cause Mortality - Number of Participant Deaths [ Time Frame: Week 6 and EOT (up to Week 12) ] [ Designated as safety issue: Yes ]
    Number of participant deaths reported at Week 6 and at EOT (up to Week 12).

  • Attributable Mortality - Number of Participant Deaths [ Time Frame: Weeks 6 and EOT (up to Week 12) ] [ Designated as safety issue: Yes ]
    Number of participant deaths attributable to study drug reported at Week 6 and at EOT (up to Week 12).

  • Time to Death [ Time Frame: Baseline up to 1 month post treatment ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: May 2009
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Children from 2 to 17 years who have possible, probable or proven invasive aspergillosis, or other rare mold infection (eg, Scedosporium and Fusarium).
Drug: Voriconazole

All subjects will receive voriconazole for a minimum of 6 weeks and a maximum of 12 weeks. All subjects must receive intravenous (IV) voriconazole for the first week of therapy.

Group 1: Subjects 2 to 11 years old and subjects 12 to 14 years old with low body weight (<50 kg) will receive 9 mg/kg IV every 12 hours (q12h) on day 1, then 8 mg/kg IV q12h starting day 2. If there is a significant clinical improvement after the first week of IV therapy, subjects may be switched to the step-down oral regimen (9 mg/kg PO q12h with a maximum dose of 350 mg PO q12h) at the discretion of the investigator.

Group 2: Subjects 12 to 17 years old (excluding 12-14-year-olds weighing <50 kg) will receive 6 mg/kg IV q12h on day 1, then 4 mg/kg IV q12h starting day 2. Similar to Group 1, subjects may be switched to the step-down oral regimen (200 mg PO q12h) at the discretion of the investigator. Oral voriconazole can be administered as tablet or oral suspension.


  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Immunocompromised with clinically compatible illness.
  • Diagnosis of proven or probable or possible Invasive Aspergillosis (based on a modified version of the revised EORTC/MSG consensus definitions).
  • Diagnosis of infection due to Scedosporium or Fusarium species.
  • Male and female from 2 to 17 years of age.
  • Females with childbearing potential must have negative pregnancy test and be using appropriate contraception.

Exclusion Criteria:

  • Allergy or hypersensitivity to the azole drugs.
  • Female subjects who are pregnant or lactating.
  • Patients who received more than four days of antifungal drugs to treat the current episode of invasive aspergillosis or rare mold infection.
  • Received within 24 hours prior to enrollment drugs that may cause QT interval prolongation.
  • Significant liver, kidney or heart dysfunction.
  • Not expected to survive for at least 5 days.
  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: NCT00836875

Locations
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90027
Pfizer Investigational Site
Oakland, California, United States, 94609
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States, 23219
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T3B 6A8
Czech Republic
Pfizer Investigational Site
Brno, Czech Republic, 62500
Pfizer Investigational Site
Brno, Czech Republic, 625 00
Netherlands
Pfizer Investigational Site
Nijmegen, Netherlands, 6500 HB
Poland
Pfizer Investigational Site
Wroclaw, Poland, 50-345
Singapore
Pfizer Investigational Site
Singapore, Singapore, 117599
Pfizer Investigational Site
Singapore, Singapore, 229899
Spain
Pfizer Investigational Site
Barcelona, Spain, 08035
Pfizer Investigational Site
Madrid, Spain, 28041
Thailand
Pfizer Investigational Site
Bangkok noi, Bangkok, Thailand, 10700
Pfizer Investigational Site
Patumwan, Bangkok, Thailand, 10330
Pfizer Investigational Site
Rajathevee, Bangkok, Thailand, 10400
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00836875     History of Changes
Other Study ID Numbers: A1501080
Study First Received: February 3, 2009
Results First Received: May 9, 2014
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Pediatrics voriconazole invasive fungal infection invasive aspergillosis immunocompromized

Additional relevant MeSH terms:
Aspergillosis
Dermatomycoses
Hyalohyphomycosis
Infection
Mycoses
Skin Diseases
Skin Diseases, Infectious
Voriconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014