This is a study to investigate the safety and efficacy of voriconazole for the treatment of candidemia in critically ill non-neutropenic...
Date First Received: September 9, 2005
Last Updated: October 11, 2006
Verified by: Pfizer, October 2006
Clinical Trial Phase: Phase 3 | Start Date: September 2000
Overall Status: Completed
Estimated Enrollment: 400
Brief Summary
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.”
Condition Keyword(s):
This is a study to investigate the safety and efficacy of voriconazole for the treatment of candidemia in critically ill non-neutropenic patients
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: VFEND® I.V., Oral
- Drug: Conventional amphotericin B
- Drug: Diflucan IV, oral
Outcome Measures for this Clinical Trial
Primary Measures
- Sustained clinical response for 12 weeks from end of treatment
Secondary Measures
- Time to negative blood cultures
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients with candidemia
Exclusion Criteria:
- Neutropenia
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00163111
Study ID Number: A1500608
ClinicalTrials.gov Identifier: NCT00163111
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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