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Ceftazidime Pharmacokinetic in Cerebrospinal Fluid Between Continuous and Intermittent Administration

Primary Purpose

Pseudomonas Aeruginosa Meningitis

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ceftazidime
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pseudomonas Aeruginosa Meningitis focused on measuring Ceftazidime, Pharmacokinetics, Pseudomonas, aeruginosa, Meningitis, Patients, hospitalised, cerebrolesion, acquired, pneumopathy, mechanic, ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients aged over 18 years old,
  • patients hospitalised for a cerebrolesion associated to a hydrocephalus drained by an external ventricular derivation, an acquired pneumopathy under mechanic ventilation since more 7 days in the department of neurological intensive care

Exclusion Criteria:

  • patients treated by ceftazidime 15 days before the beginning of this study

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 13, 2007
    Last Updated
    January 18, 2011
    Sponsor
    University Hospital, Clermont-Ferrand
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00752882
    Brief Title
    Ceftazidime Pharmacokinetic in Cerebrospinal Fluid Between Continuous and Intermittent Administration
    Official Title
    Comparison of Ceftazidime Pharmacokinetic in Cerebrospinal Fluid Between Continuous and Intermittent Administration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2009 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Hospital, Clermont-Ferrand

    4. Oversight

    5. Study Description

    Brief Summary
    Meningitis is an infection where morbidity and mortality depend on the delay of the initial treatment for a good prognostic. The antibiotherapy rapidity allows to decrease the mortality. Intermittent administration of ceftazidime is a reference treatment of Pseudomonas aeruginosa meningitis. In the case of Pseudomonas aeruginosa pneumopathy, ceftazidime can be administered by intermittent injections or by continuous perfusion. The continuous administration of ceftazidime is not validated in Pseudomonas aeruginosa meningitis. However, ceftazidime is a time dependant antibiotic and continuous treatment would provide a more efficient therapeutic. The aim of this study is to determine if the continuous administration of ceftazidime could permit a better therapeutic practice of Pseudomonas aeruginosa meningitis compared with intermittent administrations.
    Detailed Description
    This study will compare the administration of ceftazidime by intermittent intravenous injections (29 mg/kg 30min ×3/day) and by continuous infusion (86 mg/kg/24 h, preceded by 29 mg/kg/30 min). The main evaluation criterion of the study is the measure of the time during which ceftazidime concentration is above minimal inhibitive concentration of Pseudomonas aeruginosa in cerebrospinal fluid. This study will be developed in a neurological intensive care department. Inclusion criteria will be essentially, patients aged over 18 years old, hospitalised for a cerebrolesion associated to a hydrocephalus drained by an external ventricular derivation, an acquired pneumopathy under mechanic ventilation since more 7 days in the department of neurological intensive care. This study is a prospective randomised, simple blind and divided in two parts. The first part of the study is a study with parallel group comparing the treatment initiation between a continuous and an intermittent treatment of ceftazidime. The second part of the study is a cross-over study. One patient group will receive a continuous treatment of ceftazidime and the other patient group will receive an intermittent treatment of ceftazidime.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pseudomonas Aeruginosa Meningitis
    Keywords
    Ceftazidime, Pharmacokinetics, Pseudomonas, aeruginosa, Meningitis, Patients, hospitalised, cerebrolesion, acquired, pneumopathy, mechanic, ventilation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ceftazidime

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients aged over 18 years old, patients hospitalised for a cerebrolesion associated to a hydrocephalus drained by an external ventricular derivation, an acquired pneumopathy under mechanic ventilation since more 7 days in the department of neurological intensive care Exclusion Criteria: patients treated by ceftazidime 15 days before the beginning of this study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Patrick Lacarin, DRC
    Phone
    04 73 75 11 95
    Email
    placarin@chu-clermontferrand.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christelle Tarbouriech, Dr
    Organizational Affiliation
    University Hospital, Clermont-Ferrand
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Ceftazidime Pharmacokinetic in Cerebrospinal Fluid Between Continuous and Intermittent Administration

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