A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients With Persistent Fever and Neutropenia

This study has been completed.

First Received on January 18, 2001. Last Updated on August 26, 2010 History of Changes

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00008840

Purpose

The purpose of this study is to evaluate the safety and effectiveness of 2 drugs (AmBisome versus voriconazole) in treating fungal infections. Immunocompromised patients, especially those with persistent fever and neutropenia, are at a high risk of developing deeply invasive, life-threatening fungal infections with Candida, Aspergillus, and other opportunistic fungal pathogens. The risk of fungal infection increases in direct proportion with severity of neutropenia and duration of fever. Antifungal therapy, therefore, is an important step in the amelioration of fungal disease.

Condition
Neutropenia

Study Type:	Observational
Official Title:	A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients With Persistent Fever and Neutropenia

Resource links provided by NLM:

Genetics Home Reference related topics: cyclic neutropenia

MedlinePlus related topics: Fever Fungal Infections Molds

Drug Information available for: Voriconazole Amphotericin B

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:	866
Estimated Study Completion Date:	November 2005

Detailed Description:

Patients are first split into groups to receive either voriconazole or AmBisome. Both drugs are given through a vein (IV) for at least 3 days. At the conclusion of 3 days, the voriconazole patients are then switched to oral voriconazole. The AmBisome patients continue with IV AmBisome. Both groups continue treatment until blood counts increase and fever subsides.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

You may be eligible for this study if you:

Are at least 12 years of age.
Are hospitalized with low white blood cell counts.
Have received at least 96 hours of IV antibiotics.
Have an oral temperature (or equivalent) of 38.0 C (100.4 F) or greater within the 24 hours before the study starts.
Are not pregnant or breast-feeding.
Agree to use a barrier method of contraception (e.g., a condom) during the study

Exclusion Criteria:

You will not be eligible for this study if you:

Have a serious fungal infection.
Have a history of an allergic reaction to antifungal agents.
Are taking certain medications which may interfere with the study drug.
Are participating in a clinical trial of any investigational drug.
Have previously participated in this trial.
Have any conditions which could affect your safety, make evaluation of response difficult, or make it unlikely that you can complete the course of therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008840

Locations

United States, Alabama
Mary Ellen Bradley
Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00008840 History of Changes
Other Study ID Numbers:	DMID MSG 42, 150-603
Study First Received:	January 18, 2001
Last Updated:	August 26, 2010
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Liposomal amphotericin B
Antifungal Agents
Voriconazole

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

ClinicalTrials.gov processed this record on February 13, 2012