NCT00162578

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2002

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

July 23, 2007

Status Verified

July 1, 2007

First QC Date

September 9, 2005

Last Update Submit

July 20, 2007

Conditions

Pneumococcal Meningitis

Keywords

pneumococcal meningitisintensive care unitvancomycindexamethasonedrug diffusion in cerebrospinal fluid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Allergy to one of the antibiotics used in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Service de Réanimation Médicale, CHU Louis Mourier

Colombes, 92700, France

Location

Service de Réanimation Médicale, CHU Bichat

Paris, 75018, France

Location

Service de Réanimation Médicale, CHI Poissy-St-Germain

Poissy, 78300, France

Location

Related Publications (5)

  • 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. doi: 10.1086/425368. Epub 2004 Oct 6. No abstract available.

    PMID: 15494903BACKGROUND

  • 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. doi: 10.1056/NEJMoa021334.

    PMID: 12432041BACKGROUND

  • 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. doi: 10.1164/ajrccm.165.5.2105110.

    PMID: 11874820BACKGROUND

  • 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. doi: 10.1128/AAC.35.12.2467.

    PMID: 1810180BACKGROUND

  • Ricard JD, Wolff M, Lacherade JC, Mourvillier B, Hidri N, Barnaud G, Chevrel G, Bouadma L, Dreyfuss D. Levels of vancomycin in cerebrospinal fluid of adult patients receiving adjunctive corticosteroids to treat pneumococcal meningitis: a prospective multicenter observational study. Clin Infect Dis. 2007 Jan 15;44(2):250-5. doi: 10.1086/510390. Epub 2006 Dec 15.

    PMID: 17173226DERIVED

MeSH Terms

Conditions

Meningitis, Pneumococcal

Condition Hierarchy (Ancestors)

Meningitis, BacterialCentral Nervous System Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPneumococcal InfectionsStreptococcal InfectionsGram-Positive Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory Diseases

Study Officials

  • Jean-Damien Ricard, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Didier DREYFUSS, MD

    Assistance Publique - Hôpitaux de Paris

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

December 1, 2002

Study Completion

November 1, 2005

Last Updated

July 23, 2007

Record last verified: 2007-07

Locations

FR(3)