Pharmacological Study of High Doses of Ceftriaxone in Meningitidis

Meningitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745679
• Other study ID #: RC12_0171
• Status: Completed
• Phase: Phase 4
• First received: December 4, 2012
• Last updated: October 4, 2016
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: October 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France:ANSM
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Infection
• Meningitis
• Neurological Infections

Intervention

Drug:
• Ceftriaxone treatment
ceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day

Locations

Country	Name	City	State
France	Angers Universitary Hospital	Angers
France	La Roche/Yon hospital	La Roche/Yon
France	Nantes Universitary Hospital	Nantes	Loire Atlantique
France	Poitiers Universitary hospital	Poitiers
France	Rennes Universitary hospital	Rennes
France	St Nazaire hospital	St Nazaire
France	Tours universitary hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasmatic concentration of ceftriaxone, measured at the steady state (after 48 hours of treatment at least).		after at least 48 hours of ceftriaxone treatment	No
Secondary	Neurological troubles	Neurological troubles explored by electroencephalogram aiming to diagnose epileptic syndrome.	participants will be followed for the duration of ceftriaxone treatment, an expected average of two weeks	Yes
Secondary	clinical evolution	Time of return to apyrexia, health complications and lenght of hospital stay will be registered.	participants will be followed for the duration of ceftriaxone treatment, an expected average of 2 weeks	No