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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Fever Fungal Infections

Drug Information available for: Caspofungin Caspofungin Acetate

U.S. FDA Resources

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:	May 2004
Study Completion Date:	August 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

Publications:

Neely M, Jafri HS, Seibel N, Knapp K, Adamson PC, Bradshaw SK, Strohmaier KM, Sun P, Bi S, Dockendorf MF, Stone JA, Kartsonis NA. Pharmacokinetics and safety of caspofungin in older infants and toddlers. Antimicrob Agents Chemother. 2009 Apr;53(4):1450-6. Epub 2008 Dec 29.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_099, MK0991-042
Study First Received:	February 14, 2006
Last Updated:	October 26, 2009
ClinicalTrials.gov Identifier:	NCT00292071 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Echinocandins
Hematologic Diseases
Caspofungin
Agranulocytosis
Leukocyte Disorders
Infection

Pharmacologic Actions
Mycoses
Neutropenia
Antifungal Agents
Therapeutic Uses
Leukopenia

ClinicalTrials.gov processed this record on November 27, 2009