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
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
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
NCT ID
NCT00752882
First Posted
September 13, 2007
Last Updated
January 18, 2011
Sponsor
University Hospital, Clermont-Ferrand
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
Learn more about this trial
Ceftazidime Pharmacokinetic in Cerebrospinal Fluid Between Continuous and Intermittent Administration
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