MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00082537

Purpose

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	Intervention	Phase
Neutropenia Fever	Drug: caspofungin acetate Drug: Comparator: AmBisome	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Single Group Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Fever

Drug Information available for: Caspofungin Caspofungin Acetate Amphotericin B

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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:

Proportion of patients with a favorable overall response

Enrollment:	100
Study Start Date:	June 2004
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Duration of Treatment: 28-90 days

Eligibility

Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082537

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_101, Formerly-0404ETPP, MK0991-044
Study First Received:	May 11, 2004
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00082537 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Abelcet
Amphotericin B
Hematologic Diseases
Caspofungin
Agranulocytosis
Leukocyte Disorders
Liposomal amphotericin B

Granulocytopenia
Fever
Neutropenia
Anti-Bacterial Agents
Antifungal Agents
Leukopenia

Additional relevant MeSH terms:

Amphotericin B
Anti-Infective Agents
Antiprotozoal Agents
Hematologic Diseases
Caspofungin
Agranulocytosis
Leukocyte Disorders
Pharmacologic Actions

Anti-Bacterial Agents
Neutropenia
Antiparasitic Agents
Antifungal Agents
Therapeutic Uses
Amebicides
Leukopenia

ClinicalTrials.gov processed this record on July 02, 2009