Pharmacological Study of High Doses of Ceftriaxone in Meningitidis

Phase 4

Completed

• Conditions: Meningitis; Neurological Infections
• Interventions: Drug: Ceftriaxone treatment

• Registration Number: NCT01745679
• Lead Sponsor: Nantes University Hospital

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-10
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (7)

Angers Universitary Hospital; 🇫🇷 Angers, France

Nantes Universitary Hospital; 🇫🇷 Nantes, Loire Atlantique, France

La Roche/Yon hospital; 🇫🇷 La Roche/Yon, France

Poitiers Universitary hospital; 🇫🇷 Poitiers, France

Rennes Universitary hospital; 🇫🇷 Rennes, France

Tours universitary hospital; 🇫🇷 Tours, France

St Nazaire hospital; 🇫🇷 St Nazaire, France