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Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children

Primary Purpose

Neutropenia, Cancer, Fever

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cloxacillin and amikacin (once or twice daily dosage)
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neutropenia focused on measuring febrile neutropenia, once-daily, amikacin, cloxacillin, children

Eligibility Criteria

1 Year - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 1 year - 14 years A single oral temperature of >/= 38.3 degrees C; or >/= 38.0 degrees C for >/= 1 hour. Neutropenia: neutrophil count, < 500/cu mm or <1,000/cu mm with a predicted decrease to <500/mm3. During the course of chemotherapy Exclusion Criteria: History of amikacin or cloxacillin allergy Creatinine clearance < 30 ml/min/m2 Central nervous system infection: meningitis or brain abscess History of hearing abnormality Severely ill: shock Chronic liver diseases or SGPT > 10 times of upper normal limit Received aminoglycoside within 14 days prior to enrolment Received any intravenous antibiotics within 7 days Cancer which is newly diagnosed or relapsed

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Afebrile within 5 days of the initial treatment regimen
    Nephrotoxicity and ototoxicity

    Secondary Outcome Measures

    Cost difference
    Pharmacokinetic parameters of amikacin in these children

    Full Information

    First Posted
    August 10, 2005
    Last Updated
    September 22, 2005
    Sponsor
    Khon Kaen University
    Collaborators
    National Research Council of Thailand
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00129688
    Brief Title
    Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children
    Official Title
    Comparison of Efficacy, Safety and Economic Outcomes Between Once-Daily Versus Twice-Daily Amikacin in Combination With Cloxacillin in Febrile Neutropenic Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Khon Kaen University
    Collaborators
    National Research Council of Thailand

    4. Oversight

    5. Study Description

    Brief Summary
    Once-daily dose administration of aminoglycoside in adults is effective and economical. However, its value in febrile neutropenic children, especially in Thailand, is less well researched. In the area where Pseudomonas aeruginosa prevalence in febrile neutropenic children is low, the combination of cloxacillin and amikacin is an appropriate approach. This study would like to compare the efficacy and safety including cost between these two amikacin administrations (once-daily or twice-daily) in combination with cloxacillin as an empirical therapy in febrile neutropenic children. Hypothesis: Once-daily amikacin plus cloxacillin can be used to treat febrile neutropenic children in Khon Kaen, Thailand.
    Detailed Description
    Fever: a single oral temperature of >/= 38.3 degrees C; or >/= 38.0 degrees C for >/= 1 hour. Neutropenia: neutrophil count, < 500/cu mm or <1,000/cu mm with a predicted decrease to <500/mm3.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neutropenia, Cancer, Fever
    Keywords
    febrile neutropenia, once-daily, amikacin, cloxacillin, children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    166 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    cloxacillin and amikacin (once or twice daily dosage)
    Primary Outcome Measure Information:
    Title
    Afebrile within 5 days of the initial treatment regimen
    Title
    Nephrotoxicity and ototoxicity
    Secondary Outcome Measure Information:
    Title
    Cost difference
    Title
    Pharmacokinetic parameters of amikacin in these children

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 1 year - 14 years A single oral temperature of >/= 38.3 degrees C; or >/= 38.0 degrees C for >/= 1 hour. Neutropenia: neutrophil count, < 500/cu mm or <1,000/cu mm with a predicted decrease to <500/mm3. During the course of chemotherapy Exclusion Criteria: History of amikacin or cloxacillin allergy Creatinine clearance < 30 ml/min/m2 Central nervous system infection: meningitis or brain abscess History of hearing abnormality Severely ill: shock Chronic liver diseases or SGPT > 10 times of upper normal limit Received aminoglycoside within 14 days prior to enrolment Received any intravenous antibiotics within 7 days Cancer which is newly diagnosed or relapsed
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pope - Kosalaraksa, M.D.
    Organizational Affiliation
    Faculty of Medicine, Khon Kaen University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children

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