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.

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: September 9, 2005
Last updated: April 25, 2011
Last verified: April 2011
This is a study to investigate the safety and efficacy of voriconazole for the treatment of candidemia in critically ill non-neutropenic patients

Condition Intervention Phase
Drug: VFEND® I.V., Oral
Drug: Conventional amphotericin B
Drug: Diflucan IV, oral
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Sustained clinical response for 12 weeks from end of treatment

Secondary Outcome Measures:
  • Time to negative blood cultures

Enrollment: 412
Study Start Date: September 1998
Study Completion Date: May 2003

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with candidemia

Exclusion Criteria:

  • Neutropenia
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00163111

Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00163111     History of Changes
Other Study ID Numbers: 608, A1500608
Study First Received: September 9, 2005
Last Updated: April 25, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Candidiasis, Invasive
Pathologic Processes
Systemic Inflammatory Response Syndrome
Amphotericin B
Liposomal amphotericin B
14-alpha Demethylase Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 30, 2015