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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00082537
Recruitment Status : Completed
First Posted : May 13, 2004
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neutropenia Fever Drug: caspofungin acetate Drug: Comparator: AmBisome Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arms and Interventions
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Intervention Details:
  • Drug: caspofungin acetate
    Duration of Treatment: 28-90 days
    Other Name: MK0991
  • Drug: Comparator: AmBisome
    Duration of Treatment: 28-90 days

Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Proportion of patients with a favorable overall response

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082537


Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
More Information
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Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications of Results:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT00082537    
Other Study ID Numbers: 0991-044
Formerly-0404ETPP
MK0991-044
2004_101
First Posted: May 13, 2004    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Neutropenia
Fever
Body Temperature Changes
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Caspofungin
 Liposomal amphotericin B
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiprotozoal Agents
Antiparasitic Agents