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Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia (0991-042)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fungal Infection

Intervention: caspofungin acetate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults.

Secondary outcome: Caspofungin is generally safe and well tolerated in children 3 to 24 months of age.

Eligibility

Minimum age: 3 Months. Maximum age: 24 Months. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Related 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. doi: 10.1128/AAC.01027-08. Epub 2008 Dec 29.

Starting date: May 2004
Last updated: December 7, 2014

Page last updated: August 20, 2015

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