A Clinical Study Intended To Compare Treatment With Voriconazole To Treatment With Amphotericin Followed By Fluconazole In Patients With Candidemia, A Serious Fungus Infection Of The Blood.
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis
Intervention: VFEND® I.V., Oral (Drug); Conventional amphotericin B (Drug); Diflucan IV, oral (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
This is a study to investigate the safety and efficacy of voriconazole for the treatment of
candidemia in critically ill non-neutropenic patients
Clinical Details
Official title: A Randomized, Open Label, Comparative Multicenter Study Of Voriconazole Versus Conventional Amphotericin B Followed By Fluconazole In The Treatment Of Candidaemia In Non Neutropenic Subjects.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Sustained clinical response for 12 weeks from end of treatment
Secondary outcome: Time to negative blood cultures
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with candidemia
Exclusion Criteria:
- Neutropenia
Locations and Contacts
Additional Information
Starting date: September 2000
Ending date: November 2003
Last updated: October 11, 2006
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