MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients (0991-044)
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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.
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
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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To estimate the proportion of patients treated with caspofungin reporting one or more clinical and/or laboratory drug-related adverse experience(s) during the study drug therapy period plus 14 days posttherapy
Secondary Outcome Measures :
Proportion of patients with a favorable overall response
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Ages Eligible for Study:
2 Years to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients who are 2 through 17 years of age
Absolute Neutrophil Count (ANC) is below 500/microliter
Have persistent fever (at least 4 days) despite antibiotic therapy