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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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 Aspergillosi

Brief Summary: 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.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: 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 ]

Original Primary Outcome: The primary endpoint is safety and tolerability throughout the study including the follow-up visit. [ Time Frame: 2 years ]

Current Secondary Outcome:

• Percentage of Participants With a Global Response of Success [ Time Frame: Weeks 6 and End of Treatment (EOT; up to Week 12) ]
  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) ]
  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) ]
  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 ]

Original Secondary Outcome:

• Rate of global response at End of Treatment. [ Time Frame: 2 years ]
• All cause mortality at 6 and 12 weeks. [ Time Frame: 2 years ]
• Time to death. [ Time Frame: 2 years ]
• Description of the serum Aspergillus galactomannan antigenemia at EOT in relation to global response. [ Time Frame: 2 years ]

Dates:
Date Received: February 3, 2009
Date Started: May 2009
Date Completion:
Last Updated: August 16, 2016
Last Verified: August 2016