- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00752882
Ceftazidime Pharmacokinetic in Cerebrospinal Fluid Between Continuous and Intermittent Administration
January 18, 2011 updated by: University Hospital, Clermont-Ferrand
Comparison of Ceftazidime Pharmacokinetic in Cerebrospinal Fluid Between Continuous and Intermittent Administration
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Patrick Lacarin, DRC
- Phone Number: 04 73 75 11 95
- Email: placarin@chu-clermontferrand.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christelle Tarbouriech, Dr, University Hospital, Clermont-Ferrand
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion (Anticipated)
June 1, 2009
Study Registration Dates
First Submitted
September 13, 2007
First Submitted That Met QC Criteria
September 15, 2008
First Posted (Estimate)
September 16, 2008
Study Record Updates
Last Update Posted (Estimate)
January 19, 2011
Last Update Submitted That Met QC Criteria
January 18, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-0025
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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