NCT01745679

Pharmacological Study of High Doses of Ceftriaxone in Meningitidis

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Meningitis
• Neurological Infections

Interventions

Type	Name	Description
DRUG	Ceftriaxone treatment	ceftriaxone will be administered à high dose : \> or equal to 75mg/kg/day or 4 gr/day

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-12-10
• Last updated: 2016-10-05

Locations

7 sites across 1 country: France