Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia - Full Text View

Purpose

This is an open-label study of MK0991 in children between 3 to 24 months of age with new onset fever and neutropenia. The purpose of the study is to investigate plasma drug levels of caspofungin.

Condition	Intervention	Phase
Fungal Infection	Drug: caspofungin acetate	Phase II

MedlinePlus related topics:

Fever Fungal Infections

ChemIDplus related topics:

Caspofungin Caspofungin Acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Official Title:	A Multicenter, Open, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of 2 Separate Doses of Caspofungin Acetate in Children Between the Ages of 3 to 24 Months With New Onset Fever and Neutropenia

Further study details as provided by Merck:

Primary Outcome Measures:

Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Caspofungin is generally safe and well tolerated in children 3 to 24 months of age. [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]

Enrollment:	16
Study Start Date:	February 2006
Study Completion Date:	February 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 IV caspofungin acetate (50 mg/m²/day)	Drug: caspofungin acetate (50 mg/m²/day and 70 mg/m²/day) Caspofungin will be given for a minimum of 4 days (or at least 2 separate days of 7-point plasma sampling). Patients will be administered caspofungin for a maximum of 28 days.
2 IV caspofungin acetate (70 mg/m²/day)	Drug: caspofungin acetate (50 mg/m²/day and 70 mg/m²/day) Caspofungin will be given for a minimum of 4 days (or at least 2 separate days of 7-point plasma sampling). Patients will be administered caspofungin for a maximum of 28 days.

Eligibility

Ages Eligible for Study:	3 Months to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is 3 to 24 months of age with one or more of the following conditions:
Leukemia, lymphoma, or other cancers
Bone marrow or peripheral stem transplantation
High dose chemotherapy leading to a decrease in white blood cells
Aplastic anemia
Patient has an absolute neutrophil count <500 mm3 (a specific type of white blood cell that fights infection) AND at least one recording of fever > 38 degreesC (oral or oral equivalent) within 72 hours of screening.

Exclusion Criteria:

Patient is <3 months or >24 months of age at the time of study drug administration
Patient has proven or probable invasive fungal infection at the time of enrollment
Patient has certain blood clotting or liver function abnormalities
Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days
Patient is taking rifampin, cyclosporin A, phenytoin, carbamazepine, or phenobarbital.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292071

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_099, MK0991-042
First Received:	February 14, 2006
Last Updated:	December 23, 2007
ClinicalTrials.gov Identifier:	NCT00292071
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Fever

Neutropenia

Mycoses

Clotrimazole

Hematologic Diseases

Miconazole

Caspofungin

Tioconazole

Agranulocytosis

Leukocyte Disorders

Leukopenia

Granulocytopenia

Additional relevant MeSH terms:

Anti-Infective Agents

Therapeutic Uses

Antifungal Agents

Infection

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00292071