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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.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00163111
First received: September 9, 2005
Last updated: April 25, 2011
Last verified: April 2011
  Purpose

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
Candidiasis
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
  Eligibility

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

Inclusion Criteria:

  • Patients with candidemia

Exclusion Criteria:

  • Neutropenia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163111

Sponsors and Collaborators
Pfizer
Investigators
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:
Candidemia
Candidiasis
Candidiasis, Invasive
Fungemia
Infection
Inflammation
Mycoses
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome
Amphotericin B
Fluconazole
Liposomal amphotericin B
Voriconazole
14-alpha Demethylase Inhibitors
Amebicides
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 20, 2014