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A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients with Persistent Fever and Neutropenia Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients with Persistent Fever and Neutropenia conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients with Persistent Fever and Neutropenia Clinical research trials and A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients with Persistent Fever and Neutropenia health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients with Persistent Fever and Neutropenia. A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients with Persistent Fever and Neutropenia Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a 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. Subjects oftentimes recieve the most effective healthcare possible for their A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients with Persistent Fever and Neutropenia condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients with Persistent Fever and Neutropenia  A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients with Persistent Fever and Neutropenia
A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients with Persistent Fever and Neutropenia
For Condition: Neutropenia
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 866
Location and Contact Information:
Mary Ellen Bradley
Birmingham, Alabama, 35294
United States
Additional Information:
Study ID Numbers: DMID MSG 42; 150-603
Study Start Date:
Record last reviewed: January 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008840
Other Neutropenia Studies:
1. Cyclosporine in Treating Patients With Low Blood Counts Caused By Hematologic Cancer
2. A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children with New Onset Fever and Neutropenia
3. Voriconazole vs. Amphotericin B in the Treatment of Invasive Aspergillosis
4. Treatment of neutropenic patients with fever who are suspected to have a gram positive infection (a specific kind of bacteria)
5. Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia
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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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