Pharmacological Study of High Doses of Ceftriaxone in Meningitidis

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 4

Conditions: Meningitis; Neurological Infections

Treatments: Drug: Ceftriaxone treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01745679

RC12_0171

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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198 participants in 1 patient group

Ceftriaxone treatment

Experimental group

Description:

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

Treatment:

Drug: Ceftriaxone treatment