Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162578
Status:
COMPLETED
Last Update Posted:
2007-07-23
First Post:
2005-09-09
Brief Title:
Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis Treated With Dexamethasone
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 recommendedIDSA Guidelines CID 2004 At the same time peripheral blood was taken In both samples vancomycin concentration was determined
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 recommendedIDSA Guidelines CID 2004 At the same time peripheral blood was taken In both samples vancomycin concentration was determined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None