Expired Study
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Birmingham, Alabama 35294


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

DMID MSG 42


NCT ID:

NCT00008840


Secondary ID:

150-603


Study Acronym:


Brief Title:

A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients W


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:

N/A


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

866


Enrollment Type:


Study Dates

Completion Date:November 2005
Verification Date:November 2005
Last Changed Date:August 26, 2010
First Received Date:January 18, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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