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.

First Received on September 9, 2005. Last Updated on April 25, 2011 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00163111

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: VFENDÂ® I.V., Oral Drug: Conventional amphotericin B Drug: Diflucan IV, oral	Phase III

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:

MedlinePlus related topics: Fungal Infections Yeast Infections

Drug Information available for: Fluconazole Voriconazole Amphotericin B

U.S. FDA Resources

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

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:

Candidiasis
Candidemia
Mycoses
Fungemia
Sepsis
Infection
Candidiasis, Invasive
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Amphotericin B
Liposomal amphotericin B
Fluconazole

Voriconazole
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012