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

NCT00008840 | Completed

• 2 other identifiers: DMID MSG 42150-603
• Study Type: observational
• Target: 866
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neutropenia

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Mary Ellen Bradley

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Neutropenia

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 18, 2001
• First Posted: August 31, 2001
• Study Completion: November 1, 2005
• Last Updated: August 27, 2010

Record last verified: 2005-11

Locations

US (1)