Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis

July 20, 2007 updated by: Assistance Publique - Hôpitaux de Paris

Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis Treated With Dexamethasone

Adding vancomycin to the antibiotic regimen is recommended for the treatment of pneumococcal meningitis in adults. Use of dexamethasone as adjunct therapy has proved to reduce mortality and neurologic sequelae in adult patients with pneumococcal meningitis. However, use of dexamethasone may impair penetration of vancomycin in cerebrospinal fluid. In a purely observational manner, we thought to measure blood and CSF concentrations of vancomycin in adult patients with pneumococcal meningitis, treated with vancomycin, third-generation cephalosporin and dexamethasone.

Study Overview

Status

Completed

Conditions

Detailed Description

Because of a considerable increase in streptococcus pneumoniae meningitis with penicillin nonsusceptible strains, it is now largely recommended to add vancomycin to the third-generation cephalosporin antibiotic regimen. It has also been recently shown that use of dexamethasone reduces mortality and unfavorable outcome in adults with pneumococcal meningitis. However, concern has arisen, that dexamethasone may impair penetration of vancomycin in cerebrospinal fluid.

We therefore thought to measure in a purely observational study, blood and CSF vancomycin concentrations in adult patients with pneumococcal meningitis hospitalized in medical intensive care unit that received third-generation cephalosporin, vancomycin and dexamethasone. The aim of the study was to observe whether or not sufficient concentrations of vancomycin could be measured in the CSF despite the concomitant use of dexamethasone. Patients were cared for in a perfectly routine manner. There was no randomization. All patients received routine, recommended care (IDSA guidelines). There was no invasive procedure. Dexamethasone was administered according to the de Gans study (NEJM 2002). In these patients with severe meningitis, a second lumbar puncture was performed as recommended(IDSA Guidelines, CID 2004). At the same time, peripheral blood was taken. In both samples, vancomycin concentration was determined.

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Colombes, France, 92700
        • Service de Réanimation Médicale, CHU Louis Mourier
      • Paris, France, 75018
        • Service de Réanimation Médicale, CHU Bichat
      • Poissy, France, 78300
        • Service de Réanimation Médicale, CHI Poissy-St-Germain

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:

  • Adults (> 18 yr) with suspicion of pneumococcal meningitis requiring intensive care unit

Exclusion Criteria:

  • Allergy to one of the antibiotics used in the 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

  • Observational Models: Defined Population
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jean-Damien Ricard, MD, PhD, Assistance Publique - Hôpitaux de Paris
  • Study Chair: Didier DREYFUSS, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Start

December 1, 2002

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

July 23, 2007

Last Update Submitted That Met QC Criteria

July 20, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMR4

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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