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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Fever; Neutropenia

Treatments: Drug: Comparator: AmBisome; Drug: caspofungin acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00082537

Formerly-0404ETPP

2004_101

MK0991-044

0991-044

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind