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

Phase 2

Completed

• Conditions: Neutropenia; Fever

• Registration Number: NCT00082537
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2004-05-11
• Study First Submitted QC: 2004-05-12
• Study First Posted: 2004-05-13
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Proportion of patients with a favorable overall response