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.

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.

Study Overview

• Status: Completed
• Conditions: Meningitis; Neurological Infections
• Intervention / Treatment: Drug: Ceftriaxone treatment

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 Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Angers Universitary Hospital
  • La Roche/Yon, France, 85925
    • La Roche/Yon Hospital
  • Poitiers, France, 86021
    • Poitiers Universitary Hospital
  • Rennes, France, 35033
    • Rennes Universitary Hospital
  • St Nazaire, France, 44600
    • St Nazaire hospital
  • Tours, France, 37170
    • Tours universitary hospital
  • Loire Atlantique
    • Nantes, Loire Atlantique, France, 44093
      • Nantes Universitary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ceftriaxone treatment; ceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day	Drug: Ceftriaxone treatment; ceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Publications and helpful links

General Publications

• Gregoire M, Dailly E, Le Turnier P, Garot D, Guimard T, Bernard L, Tattevin P, Vandamme YM, Hoff J, Lemaitre F, Verdier MC, Deslandes G, Bellouard R, Sebille V, Chiffoleau A, Boutoille D, Navas D, Asseray N. High-Dose Ceftriaxone for Bacterial Meningitis and Optimization of Administration Scheme Based on Nomogram. Antimicrob Agents Chemother. 2019 Aug 23;63(9):e00634-19. doi: 10.1128/AAC.00634-19. Print 2019 Sep.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: December 7, 2012
• First Posted (Estimate): December 10, 2012

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 4, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Meningitis; Ceftriaxone; Adverse drug effects; Therapeutic monitoring
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Meningitis; Anti-Infective Agents; Anti-Bacterial Agents; Ceftriaxone
• Other Study ID Numbers: RC12_0171

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No