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Pharmacological Study of High Doses of Ceftriaxone in Meningitidis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01745679
First Posted: December 10, 2012
Last Update Posted: October 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nantes University Hospital
  Purpose
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
Meningitis Neurological Infections Drug: Ceftriaxone treatment Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:

MedlinePlus related topics: Meningitis
Drug Information available for: Ceftriaxone Ceftriaxone sodium
U.S. FDA Resources

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 ]

Secondary Outcome Measures:
  • Neurological troubles [ Time Frame: 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 [ Time Frame: 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.
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745679


Locations
France
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
ClinicalTrials.gov Identifier: NCT01745679     History of Changes
Other Study ID Numbers: RC12_0171
First Submitted: December 4, 2012
First Posted: December 10, 2012
Last Update Posted: October 5, 2016
Last Verified: October 2016

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

Additional relevant MeSH terms:
Infection
Meningitis
Central Nervous System Diseases
Nervous System Diseases
 Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents


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