Pharmacological Study of High Doses of Ceftriaxone in Meningitidis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Therapeutic Monitoring of Ceftriaxone, Prescribed at High Doses, in the Treatment of Meningitis and Others Neurological Infections.

Conditions
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Meningitis, Neurological Infections

Intervention / Treatment
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* Drug: Ceftriaxone treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ceftriaxone treatment<br>ceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day | Drug: Ceftriaxone treatment<br>* ceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasmatic concentration of ceftriaxone, measured at the steady state (after 48 hours of treatment at least). |  | after at least 48 hours of ceftriaxone treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological troubles | Neurological troubles explored by electroencephalogram aiming to diagnose epileptic syndrome. | 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. | participants will be followed for the duration of ceftriaxone treatment, an expected average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ceftriaxone, Adverse drug effects, Therapeutic monitoring, Meningitis