Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00162578

Collaborator

(none)

Enrollment

Locations

Duration (Months)

4.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumococcal Meningitis

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 Design

Study Type:

Observational

Actual Enrollment :

14 participants

Observational Model:

Defined Population

Time Perspective:

Prospective

Official Title:

Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis Treated With Dexamethasone

Study Start Date :

Dec 1, 2002

Actual Study Completion Date :

Nov 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Service de Réanimation Médicale, CHU Louis Mourier	Colombes	France	92700
2	Service de Réanimation Médicale, CHU Bichat	Paris	France	75018
3	Service de Réanimation Médicale, CHI Poissy-St-Germain	Poissy	France	78300

Sponsors and Collaborators

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