Clinical Trial: A Study of the Efficacy and Safety of Voriconazole for the Treatment of Fungal Infections

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open Label, Non-comparative, Multicenter Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infection

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of Vfend for the treatment of fungal infections

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • Serological response (evaluated by approved diagnostic serological tests [cryptococcosis, coccidiomycosis, and histoplasmosis]) at Weeks 2, 8, 12, and end of therapy. [ Time Frame: Weeks 2, 8, 12, and end of therapy ]
  • Clinical response (evaluated based on change of attributable symptoms, signs, and/or bronchoscopic abnormalities present at baseline, judged by investigators, at Weeks 1, 2, 4, 8, 12, and end of therapy) at Weeks 1, 2, 4, 8, 12, and end of therapy. [ Time Frame: Weeks 1, 2, 4, 8, 12 and end of therapy ]
  • Radiological response (evaluated based on all radiological abnormalities [X-ray, computed tomography scan] attributed to fungal infection compared to baseline) at Weeks 2, 8, 12, and end of therapy. [ Time Frame: Weeks 2, 8, 12, and end of therapy ]
  • Mycological response (evaluated by the presences of fungal pathogen by relevant specimen [microscopy or histopathology]) at Weeks 2, 8, 12, and end of therapy. [ Time Frame: Weeks 2, 8, 12, and end of therapy ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Global response to treatment (incorporating clinical, mycological, radiological, and serological responses as applicable) at end of therapy/Week 16. [ Time Frame: End of therapy or Week 16 ]
  • Change from baseline in laboratory parameters at Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up. [ Time Frame: Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up ]
  • Change from baseline in electrocardiogram at Week 1 and end of therapy. [ Time Frame: Week 1 and end of therapy ]
  • Incidence of adverse events at Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up. [ Time Frame: Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up ]
  • Visual safety testing at Weeks 1, 8, 12, end of therapy, Week 16, and follow-up. [ Time Frame: Weeks 1, 8, 12, end of therapy, Week 16, and follow-up ]


Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: March 27, 2008
Date Started: April 2003
Date Completion:
Last Updated: May 12, 2011
Last Verified: May 2011