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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00082537

First received: May 11, 2004

Last updated: February 20, 2017

Last verified: February 2017

History of Changes

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: cyclic neutropenia

MedlinePlus related topics: Fever

Drug Information available for: Amphotericin B Caspofungin Caspofungin acetate Liposomal Amphotericin B

Genetic and Rare Diseases Information Center resources: Granulocytopenia

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

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:	April 2004
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Duration of Treatment: 28-90 days

Other Name: MK0991

Duration of Treatment: 28-90 days

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Publications:

Maertens JA, Madero L, Reilly AF, Lehrnbecher T, Groll AH, Jafri HS, Green M, Nania JJ, Bourque MR, Wise BA, Strohmaier KM, Taylor AF, Kartsonis NA, Chow JW, Arndt CA, DePauw BE, Walsh TJ; Caspofungin Pediatric Study Group. A randomized, double-blind, multicenter study of caspofungin versus liposomal amphotericin B for empiric antifungal therapy in pediatric patients with persistent fever and neutropenia. Pediatr Infect Dis J. 2010 May;29(5):415-20. doi: 10.1097/INF.0b013e3181da2171.

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


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00082537 History of Changes
Other Study ID Numbers:	0991-044 Formerly-0404ETPP MK0991-044 2004_101
Study First Received:	May 11, 2004
Last Updated:	February 20, 2017

Additional relevant MeSH terms:


Fever Neutropenia Body Temperature Changes Signs and Symptoms Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases Caspofungin	Amphotericin B Liposomal amphotericin B Antifungal Agents Anti-Infective Agents Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 23, 2017

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