MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients (0991-044)

Merck Sharp & Dohme LLC100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Neutropenia Fever

Interventions

caspofungin acetateDRUG

Duration of Treatment: 28-90 days

Comparator: AmBisomeDRUG

Duration of Treatment: 28-90 days

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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

Outcomes

Primary Outcomes

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 Outcomes

Proportion of patients with a favorable overall response

Data from ClinicalTrials.gov

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