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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00162578 |
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 |
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Pneumococcal Meningitis |
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 |
Enrollment: | 14 |
Study Start Date: | December 2002 |
Study Completion Date: | 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Jean-Damien Ricard, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Study Chair: | Didier DREYFUSS, MD | Assistance Publique - Hôpitaux de Paris |
Study ID Numbers: | LMR4 |
Study First Received: | September 9, 2005 |
Last Updated: | July 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00162578 |
Health Authority: | France: Ministry of Health |
pneumococcal meningitis intensive care unit vancomycin dexamethasone drug diffusion in cerebrospinal fluid |
Dexamethasone Bacterial Infections Gram-Positive Bacterial Infections Central Nervous System Infections Streptococcal Infections Meningitis, Bacterial |
Vancomycin Central Nervous System Diseases Meningitis, Pneumococcal Pneumococcal Infections Dexamethasone acetate Meningitis |
Anti-Inflammatory Agents Anti-Infective Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics |
Glucocorticoids Hormones Pharmacologic Actions Anti-Bacterial Agents Autonomic Agents Therapeutic Uses Central Nervous System Bacterial Infections Peripheral Nervous System Agents Central Nervous System Agents |