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

Neutropenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00008840
• Other study ID #: DMID MSG 42
• Secondary ID: 150-603
• Status: Completed
• Phase: N/A
• First received: January 18, 2001
• Last updated: August 26, 2010
• Est. completion date: November 2005

Study information

• Verified date: November 2005
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 866
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Neutropenia

Locations

Country	Name	City	State
United States	Mary Ellen Bradley	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,