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. Identifier: NCT00082537
Recruitment Status : Completed
First Posted : May 13, 2004
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 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
Primary Completion Date : October 2006
Study Completion Date : October 2006

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

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

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

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

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 identifier (NCT number): NCT00082537

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Study Data/Documents: CSR Synopsis  This link exits the site

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00082537     History of Changes
Other Study ID Numbers: 0991-044
First Posted: May 13, 2004    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Body Temperature Changes
Signs and Symptoms
Leukocyte Disorders
Hematologic Diseases
Amphotericin B
Liposomal amphotericin B
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents