Trial record 9 of 337 for:    meningitis

Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00162578
First received: September 9, 2005
Last updated: July 20, 2007
Last verified: July 2007
  Purpose

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
Pneumococcal Meningitis

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis Treated With Dexamethasone

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Enrollment: 14
Study Start Date: December 2002
Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00162578

Locations
France
Service de Réanimation Médicale, CHU Louis Mourier
Colombes, France, 92700
Service de Réanimation Médicale, CHU Bichat
Paris, France, 75018
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00162578     History of Changes
Other Study ID Numbers: LMR4
Study First Received: September 9, 2005
Last Updated: July 20, 2007
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
pneumococcal meningitis
intensive care unit
vancomycin
dexamethasone
drug diffusion in cerebrospinal fluid

Additional relevant MeSH terms:
Meningitis
Meningitis, Pneumococcal
Meningitis, Bacterial
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Bacterial Infections
Bacterial Infections
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Vancomycin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014