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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00082537 |
This study is a double-blind, randomized study of MK0991 versus liposomal amphotericin B in the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute neutrophil count (ANC) below 500/microliter and who have fever despite broad antibiotic coverage. Such patients would be candidates for empirical therapy with an intravenous anti-fungal agent.
Condition | Intervention | Phase |
---|---|---|
Neutropenia Fever |
Drug: caspofungin acetate Drug: Comparator: AmBisome |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Single Group Assignment, Safety Study |
Official Title: | A Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Versus (Amphotericin B) Liposome for Injection as Empirical Therapy in Pediatric Patients With Persistent Fever and Neutropenia |
Enrollment: | 100 |
Study Start Date: | June 2004 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 2 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2004_101, Formerly-0404ETPP, MK0991-044 |
Study First Received: | May 11, 2004 |
Last Updated: | May 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00082537 |
Health Authority: | United States: Food and Drug Administration |
Abelcet Amphotericin B Hematologic Diseases Clotrimazole Miconazole Caspofungin Tioconazole |
Agranulocytosis Leukocyte Disorders Liposomal amphotericin B Granulocytopenia Fever Neutropenia Leukopenia |
Anti-Bacterial Agents Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents |
Antifungal Agents Therapeutic Uses Amebicides Pharmacologic Actions |