Pharmacological Study of High Doses of Ceftriaxone in Meningitidis

Nantes University Hospital198 enrolled

Overview

The aim of the study is to describe the concentrations of Ceftriaxone at the steady state, in patients treated for meningitis, to determine pharmacokinetic parameters at high dose in this population. Additionally, we aimed to detect adverse effect, especially neurological trouble related to Ceftriaxone toxicity.

Day 0 : onset of treatment by Ceftriaxone, following usual therapeutic process (French Guideline) From Day 0 to Day 4 : inclusion, clinical and biological data collection, electroencephalogram at baseline. Two samples for ceftriaxone concentration monitoring : * Trough concentration of ceftriaxone at steady state * A random sample (population PK) At the end of ceftriaxone treatment : assessment of tolerance and efficacy of the treatment.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

198

Conditions

Meningitis Neurological Infections

Interventions

Ceftriaxone treatmentDRUG

ceftriaxone will be administered à high dose : \> or equal to 75mg/kg/day or 4 gr/day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hospitalized adults patients, * age equal or above 18 * Patients with Community or surgical acquired neurological infections, meningitis and others * Prescription of ceftriaxone \>75mg/kg/d or \>4g/d - * Subjects affiliated to French health insurance (social security) * Informed consent form signed Exclusion Criteria: \- Patient under guardianship

Locations (7)

Tours universitary hospital

Tours, France, France

Nantes Universitary Hospital

Nantes, Loire Atlantique, France

Angers Universitary Hospital

Angers, France

La Roche/Yon hospital

La Roche/Yon, France

Outcomes

Primary Outcomes

plasmatic concentration of ceftriaxone, measured at the steady state (after 48 hours of treatment at least).

Time frame: after at least 48 hours of ceftriaxone treatment

Secondary Outcomes

Neurological troubles

Neurological troubles explored by electroencephalogram aiming to diagnose epileptic syndrome.

Time frame: participants will be followed for the duration of ceftriaxone treatment, an expected average of two weeks

clinical evolution

Time of return to apyrexia, health complications and lenght of hospital stay will be registered.

Time frame: participants will be followed for the duration of ceftriaxone treatment, an expected average of 2 weeks

Data from ClinicalTrials.gov

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