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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2006

Interventions

  • 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.

Arms, Groups and Cohorts

  • Other: 1
    • IV caspofungin acetate (50 mg/m²/day)
  • Other: 2
    • IV caspofungin acetate (70 mg/m²/day)

Clinical Trial Outcome Measures

Primary 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

Secondary Measures

  • Caspofungin is generally safe and well tolerated in children 3 to 24 months of age.
    • Time Frame: 28 Days

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 24 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme LLC

References

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.

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