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Pharmacological Study of High Doses of Ceftriaxone in Meningitidis

This study has been completed.
Information provided by (Responsible Party):
Nantes University Hospital Identifier:
First received: December 4, 2012
Last updated: October 4, 2016
Last verified: October 2016
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.

Condition Intervention Phase
Neurological Infections
Drug: Ceftriaxone treatment
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Therapeutic Monitoring of Ceftriaxone, Prescribed at High Doses, in the Treatment of Meningitis and Others Neurological Infections.

Resource links provided by NLM:

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • plasmatic concentration of ceftriaxone, measured at the steady state (after 48 hours of treatment at least). [ Time Frame: after at least 48 hours of ceftriaxone treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurological troubles [ Time Frame: participants will be followed for the duration of ceftriaxone treatment, an expected average of two weeks ] [ Designated as safety issue: Yes ]
    Neurological troubles explored by electroencephalogram aiming to diagnose epileptic syndrome.

  • clinical evolution [ Time Frame: participants will be followed for the duration of ceftriaxone treatment, an expected average of 2 weeks ] [ Designated as safety issue: No ]
    Time of return to apyrexia, health complications and lenght of hospital stay will be registered.

Enrollment: 198
Study Start Date: December 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01745679

Nantes Universitary Hospital
Nantes, Loire Atlantique, France, 44093
Angers Universitary Hospital
Angers, France, 49933
La Roche/Yon hospital
La Roche/Yon, France, 85925
Poitiers Universitary hospital
Poitiers, France, 86021
Rennes Universitary hospital
Rennes, France, 35033
St Nazaire hospital
St Nazaire, France, 44600
Tours universitary hospital
Tours, France, 37170
Sponsors and Collaborators
Nantes University Hospital
  More Information

Responsible Party: Nantes University Hospital Identifier: NCT01745679     History of Changes
Other Study ID Numbers: RC12_0171 
Study First Received: December 4, 2012
Last Updated: October 4, 2016
Health Authority: France:ANSM

Keywords provided by Nantes University Hospital:
Adverse drug effects
Therapeutic monitoring

Additional relevant MeSH terms:
Central Nervous System Diseases
Nervous System Diseases
Anti-Bacterial Agents
Anti-Infective Agents processed this record on October 25, 2016