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

Primary Purpose

Fungal Infection

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
caspofungin acetate
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fungal Infection

Eligibility Criteria

3 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    1

    2

    Arm Description

    IV caspofungin acetate (50 mg/m²/day)

    IV caspofungin acetate (70 mg/m²/day)

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    February 14, 2006
    Last Updated
    February 20, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00292071
    Brief Title
    Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia (0991-042)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2004 (undefined)
    Primary Completion Date
    July 2006 (Actual)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fungal Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Other
    Arm Description
    IV caspofungin acetate (50 mg/m²/day)
    Arm Title
    2
    Arm Type
    Other
    Arm Description
    IV caspofungin acetate (70 mg/m²/day)
    Intervention Type
    Drug
    Intervention Name(s)
    caspofungin acetate
    Other Intervention Name(s)
    MK0991, CANCIDAS®
    Intervention Description
    (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.
    Primary Outcome Measure Information:
    Title
    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 Outcome Measure Information:
    Title
    Caspofungin is generally safe and well tolerated in children 3 to 24 months of age.
    Time Frame
    28 Days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    24 Months
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19114680
    Citation
    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.
    Results Reference
    background
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

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

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