Pharmacological Study of High Doses of Ceftriaxone in Meningitidis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-12-31

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.

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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.

Conditions

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Meningitis Neurological Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Ceftriaxone treatment

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

Group Type EXPERIMENTAL

Ceftriaxone treatment

Intervention Type DRUG

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

Interventions

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Ceftriaxone treatment

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

Intervention Type DRUG

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