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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00082537

Enrollment

100

Registered

2004-05-13

Start date

2004-04-30

Completion date

2006-10-31

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever, Neutropenia

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.

Interventions

DRUGcaspofungin acetate

Duration of Treatment: 28-90 days

DRUGComparator: AmBisome

Duration of Treatment: 28-90 days

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Proportion of patients with a favorable overall response	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026