Tolerability of high-dose ceftriaxone in CNS infections: a prospective multicentre cohort study.


Journal

The Journal of antimicrobial chemotherapy
ISSN: 1460-2091
Titre abrégé: J Antimicrob Chemother
Pays: England
ID NLM: 7513617

Informations de publication

Date de publication:
01 04 2019
Historique:
received: 21 08 2018
revised: 14 11 2018
accepted: 28 11 2018
pubmed: 31 1 2019
medline: 26 6 2020
entrez: 31 1 2019
Statut: ppublish

Résumé

Ceftriaxone is widely used to treat community-acquired CNS bacterial infections. French guidelines for meningitis in adults promote 75-100 mg/kg/day ceftriaxone without an upper limit for dosage, yet little is known about the pharmacology and tolerability of such regimens. A multicentre prospective cohort study was conducted in adult patients to assess the adverse drug reactions (ADRs) of high-dose ceftriaxone (i.e. daily dosage ≥4 g or ≥75 mg/kg) in CNS infections and to analyse their related factors. Drug causality was systematically assessed by an expert committee who reviewed the medical charts of all included patients. A total of 196 patients were enrolled over a 31 month period. Median dosage and duration of ceftriaxone were 96.4 mg/kg/day (7 g/day) and 8 days, respectively. Nineteen ceftriaxone-related ADRs (mainly neurological) occurred in 17 patients (8.7%), with only one case of treatment discontinuation (biliary pseudolithiasis). In univariate analysis, older age, male gender, renal impairment and high trough ceftriaxone plasma concentration were associated with ceftriaxone-related ADRs. High-dose ceftriaxone for CNS infection administered as recommended by French guidelines in adults was well tolerated overall, suggesting these recommendations could be applied and generalized. In patients with advanced age or renal insufficiency, prescription should be done with caution and therapeutic drug monitoring could be useful.

Sections du résumé

BACKGROUND
Ceftriaxone is widely used to treat community-acquired CNS bacterial infections. French guidelines for meningitis in adults promote 75-100 mg/kg/day ceftriaxone without an upper limit for dosage, yet little is known about the pharmacology and tolerability of such regimens.
PATIENTS AND METHODS
A multicentre prospective cohort study was conducted in adult patients to assess the adverse drug reactions (ADRs) of high-dose ceftriaxone (i.e. daily dosage ≥4 g or ≥75 mg/kg) in CNS infections and to analyse their related factors. Drug causality was systematically assessed by an expert committee who reviewed the medical charts of all included patients.
RESULTS
A total of 196 patients were enrolled over a 31 month period. Median dosage and duration of ceftriaxone were 96.4 mg/kg/day (7 g/day) and 8 days, respectively. Nineteen ceftriaxone-related ADRs (mainly neurological) occurred in 17 patients (8.7%), with only one case of treatment discontinuation (biliary pseudolithiasis). In univariate analysis, older age, male gender, renal impairment and high trough ceftriaxone plasma concentration were associated with ceftriaxone-related ADRs.
CONCLUSIONS
High-dose ceftriaxone for CNS infection administered as recommended by French guidelines in adults was well tolerated overall, suggesting these recommendations could be applied and generalized. In patients with advanced age or renal insufficiency, prescription should be done with caution and therapeutic drug monitoring could be useful.

Identifiants

pubmed: 30698733
pii: 5304213
doi: 10.1093/jac/dky553
doi:

Substances chimiques

Anti-Bacterial Agents 0
Ceftriaxone 75J73V1629

Types de publication

Clinical Trial Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1078-1085

Informations de copyright

© The Author(s) 2019. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Auteurs

Paul Le Turnier (P)

Department of Infectious Diseases, Nantes University Hospital and CIC 1413, INSERM, Nantes, France.

Dominique Navas (D)

EA 3826, University of Nantes, Nantes, France.
Pharmacy Department, Nantes University Hospital, Nantes, France.

Denis Garot (D)

Intensive Care Unit, Anaesthesia and Critical Care Department, Tours University Hospital, Tours, France.

Thomas Guimard (T)

Infectious Diseases Department, La Roche sur Yon Hospital, La Roche sur Yon, France.

Louis Bernard (L)

Infectious Diseases Department, Tours University Hospital, Tours, France.

Pierre Tattevin (P)

Infectious Diseases Department, Rennes University Hospital, Rennes, France.

Yves Marie Vandamme (YM)

Infectious Diseases Department, Angers University Hospital, Angers, France.

Jérôme Hoff (J)

Intensive Care Unit, Anaesthesia and Critical Care Department, Saint Nazaire Hospital, Saint Nazaire, France.

Anne Chiffoleau (A)

Pharmacovigilance, Research Board, Nantes University Hospital, Nantes, France.

Martin Dary (M)

Emergency Department, Nantes University Hospital, Nantes, France.

Laurene Leclair-Visonneau (L)

Neurology and Neurophysiology Department, Nantes University Hospital, Nantes, France.

Matthieu Grégoire (M)

EA 3826, University of Nantes, Nantes, France.
Clinical Pharmacology Department, Nantes University Hospital, Nantes, France.

Morgane Pere (M)

Biostatistics Unit, Research Board, Nantes University Hospital, Nantes, France.

David Boutoille (D)

Department of Infectious Diseases, Nantes University Hospital and CIC 1413, INSERM, Nantes, France.
EA 3826, University of Nantes, Nantes, France.

Véronique Sébille (V)

Biostatistics Unit, Research Board, Nantes University Hospital, Nantes, France.

Eric Dailly (E)

EA 3826, University of Nantes, Nantes, France.
Clinical Pharmacology Department, Nantes University Hospital, Nantes, France.

Nathalie Asseray (N)

Department of Infectious Diseases, Nantes University Hospital and CIC 1413, INSERM, Nantes, France.

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