Meningitis, Neurological Infections
Conditions
Keywords
Ceftriaxone, Adverse drug effects, Therapeutic monitoring, Meningitis
Brief summary
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
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.
Interventions
ceftriaxone will be administered à high dose : \> or equal to 75mg/kg/day or 4 gr/day
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Neurological troubles | participants will be followed for the duration of ceftriaxone treatment, an expected average of two weeks | Neurological troubles explored by electroencephalogram aiming to diagnose epileptic syndrome. |
| clinical evolution | participants will be followed for the duration of ceftriaxone treatment, an expected average of 2 weeks | Time of return to apyrexia, health complications and lenght of hospital stay will be registered. |
Countries
France
Outcome results
None listed