Not Signed In -
Meningitis |
bacterial and viral |
Clinical Trial: Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis
This study is currently recruiting patients.
Verified by Assistance Publique - Hôpitaux de Paris September 2005
|
Purpose
| Condition |
|---|
| Pneumococcal Meningitis Intensive Care Unit |
MedlinePlus related topics: Bacterial Infections; Meningitis; Neurologic Diseases; Streptococcal Infections; Throat Disorders
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis Treated with Dexamethasone
Expected Total Enrollment: 15
Study start: December 2002; Expected completion: December 2005
Last follow-up: September 2005; Data entry closure: November 2005
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.
Eligibility
Inclusion Criteria:
- adults (>18 yr) with suspicion of pneumococcal meningitis requiring intensive care unit
Location and Contact Information
France
Service de Réanimation Médicale, CHU Louis Mourier, Colombes, 92700, France; Recruiting
Jean-Damien RICARD, MD, PhD, Principal Investigator
Service de Réanimation Médicale, CHU Bichat, Paris, 75018, France; Recruiting
Bruno MOURVILLIERS 33140258123 bruno.mourvilliers@bch.aphp.fr
Michel Wolff, MD, Principal Investigator
Service de Réanimation Médicale, CHI Poissy-St-Germain, Poissy, 78300, France; Recruiting
Jean-Claude LACHERADE, MD, Principal Investigator
Jean-Damien Ricard, MD, PhD, Principal Investigator, Assistance Publique - Hôpitaux de Paris
Didier DREYFUSS, MD, Study Chair, Assistance Publique - Hôpitaux de Paris
More Information
Publications
Tunkel AR, Hartman BJ, Kaplan SL, Kaufman BA, Roos KL, Scheld WM, Whitley RJ. Practice guidelines for the management of bacterial meningitis. Clin Infect Dis. 2004 Nov 1;39(9):1267-84. Epub 2004 Oct 6. No abstract available.
de Gans J, van de Beek D; European Dexamethasone in Adulthood Bacterial Meningitis Study Investigators. Dexamethasone in adults with bacterial meningitis. N Engl J Med. 2002 Nov 14;347(20):1549-56.
Auburtin M, Porcher R, Bruneel F, Scanvic A, Trouillet JL, Bedos JP, Regnier B, Wolff M. Pneumococcal meningitis in the intensive care unit: prognostic factors of clinical outcome in a series of 80 cases. Am J Respir Crit Care Med. 2002 Mar 1;165(5):713-7.
Viladrich PF, Gudiol F, Linares J, Pallares R, Sabate I, Rufi G, Ariza J. Evaluation of vancomycin for therapy of adult pneumococcal meningitis. Antimicrob Agents Chemother. 1991 Dec;35(12):2467-72.
Last Updated: September 12, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00162578
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Arachnoiditis (National Institute of Neurological Disorders and Stroke)
- Bacterial Meningitis (Cleveland Clinic)
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