Back to resultsA 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.
Primary Purpose
Candidiasis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
VFEND® I.V., Oral
Conventional amphotericin B
Diflucan IV, oral
Sponsored by
About this trial
This is an interventional treatment trial for Candidiasis
Eligibility Criteria
Inclusion Criteria: Patients with candidemia Exclusion Criteria: Neutropenia
Sites / Locations
Outcomes
Primary Outcome Measures
Sustained clinical response for 12 weeks from end of treatment
Secondary Outcome Measures
Time to negative blood cultures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00163111
Brief Title
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.
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 Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
This is a study to investigate the safety and efficacy of voriconazole for the treatment of candidemia in critically ill non-neutropenic patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
412 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
VFEND® I.V., Oral
Intervention Type
Drug
Intervention Name(s)
Conventional amphotericin B
Intervention Type
Drug
Intervention Name(s)
Diflucan IV, oral
Primary Outcome Measure Information:
Title
Sustained clinical response for 12 weeks from end of treatment
Secondary Outcome Measure Information:
Title
Time to negative blood cultures
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with candidemia
Exclusion Criteria:
Neutropenia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
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.
We'll reach out to this number within 24 hrs