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Ceftazidime Pharmacokinetic in Cerebrospinal Fluid Between Continuous and Intermittent Administration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00752882
Recruitment Status : Unknown
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
First Posted : September 16, 2008
Last Update Posted : January 19, 2011
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment Phase
Pseudomonas Aeruginosa Meningitis Drug: ceftazidime Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Comparison of Ceftazidime Pharmacokinetic in Cerebrospinal Fluid Between Continuous and Intermittent Administration
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752882


Contacts
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Contact: Patrick Lacarin, DRC 04 73 75 11 95 placarin@chu-clermontferrand.fr

Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Christelle Tarbouriech, Dr University Hospital, Clermont-Ferrand

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Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00752882    
Other Study ID Numbers: CHU-0025
First Posted: September 16, 2008    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: January 2011
Keywords provided by University Hospital, Clermont-Ferrand:
Ceftazidime
Pharmacokinetics
Pseudomonas
aeruginosa
Meningitis
Patients
hospitalised
cerebrolesion
acquired
pneumopathy
mechanic
ventilation
Additional relevant MeSH terms:
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Pseudomonas Infections
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Ceftazidime
Anti-Bacterial Agents
Anti-Infective Agents