Clinical Trial: A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients

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

Official Title: A Prospective, Open-label, Non-comparative Study To Assess The Safety, Tolerability And Efficacy Of Voriconazole For The Primary And Salvage Treatment Of Invasive Candidiasis

Brief Summary: The purpose of this study is to determine whether voriconazole is safe and effective for the treatment of serious Candida infection and Candida infection of the esophagus in children and adolescents.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Percentage of Participants With Adverse Events - Overall Summary [ Time Frame: Baseline up to 1 month follow-up ]

Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, who discontinued due to AEs, or who had dose redued or temporarily discontinued due to AEs.


Original Primary Outcome: Safety and tolerability of voriconazole, as determined by the rate of adverse events (serious and non-serious), including visual-, cardiac-, and liver related adverse effects, and treatment discontinuation due to adverse events. [ Time Frame: 1 - 72 Days ]

Current Secondary Outcome:

  • Percentage of Participants With a Global Response of Success at End of Treatment (EOT) [ Time Frame: EOT (from 7 to 42 days of treatment) ]
    Global response was determined programmatically based on investigator assessment of clinical and microbiological response. Global response of success was defined as clinical cure or improvement AND microbiological eradication or presumed eradication. Exact 95 percent (%) confidence interval for binomial proportions using Clopper-Pearson method.
  • All-Cause Mortality - Number of Participant Deaths [ Time Frame: Day 28 and 1 Month Follow-up ]
  • Time to Death [ Time Frame: Baseline up to 1 month follow-up ]


Original Secondary Outcome:

  • Efficacy, as determined by global response at the End of Treatment (EOT). [ Time Frame: 7 - 42 days ]
  • Time to death and all-cause mortality during study therapy. [ Time Frame: 1 - 72 Days ]


Information By: Pfizer

Dates:
Date Received: March 10, 2010
Date Started: October 2010
Date Completion:
Last Updated: May 17, 2016
Last Verified: May 2016