MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients (0991-044)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neutropenia; Fever
Intervention: caspofungin acetate (Drug); Comparator: AmBisome (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
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.
Clinical Details
Official title: 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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: 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: Proportion of patients with a favorable overall response
Eligibility
Minimum age: 2 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: April 2004
Last updated: September 16, 2014
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