A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients With Persistent Fever and Neutropenia
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neutropenia
Phase: N/A
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
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.
Clinical Details
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 design: N/A
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
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Mary Ellen Bradley, Birmingham, Alabama 35294, United States
Additional Information
Last updated: August 26, 2010
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