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: September 9, 2005 Last Updated: August 13, 2009 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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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: Yeast Infections

Drug Information available for: Fluconazole Voriconazole Amphotericin B

Further study details as provided by Pfizer:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	400
Study Start Date:	September 2000
Estimated Study Completion Date:	November 2003

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

Study ID Numbers:	608, A1500608
Study First Received:	September 9, 2005
Last Updated:	August 13, 2009
ClinicalTrials.gov Identifier:	NCT00163111 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Abelcet
Fluconazole
Amphotericin B
Anti-Infective Agents
Antiprotozoal Agents
Candidiasis
Liposomal amphotericin B
Pharmacologic Actions

Anti-Bacterial Agents
Mycoses
Antiparasitic Agents
Antifungal Agents
Therapeutic Uses
Voriconazole
Antibiotics, Antifungal
Amebicides

ClinicalTrials.gov processed this record on February 08, 2010