Back to resultsA Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients With Persistent Fever and Neutropenia
Primary Purpose
Neutropenia
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Neutropenia
Eligibility 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.
Sites / Locations
- Mary Ellen Bradley
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00008840
First Posted
January 18, 2001
Last Updated
August 26, 2010
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00008840
Brief Title
A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients With Persistent Fever and Neutropenia
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
Study Type
Observational
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia
7. Study Design
Enrollment
866 (false)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Mary Ellen Bradley
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients With Persistent Fever and Neutropenia
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