Pharmacological Study of High Doses of Ceftriaxone in Meningitidis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01745679
First received: December 4, 2012
Last updated: December 10, 2012
Last verified: December 2012
  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: 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.


Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745679

Contacts
Contact: Nathalie ASSERAY, PH +33 2 40 08 33 16 nasseray@chu-nantes.fr
Contact: dominique NAVAS, PH +33 2 40 08 41 54 dominique.navas@chu-nantes.fr

Locations
France
Nantes Universitary Hospital Recruiting
Nantes, Loire Atlantique, France, 44093
Contact: Nathalie ASSERAY, PH    +33 2 40 08 33 16    nasseray@chu-nantes.fr   
Principal Investigator: Nathalie ASSERAY, PH         
Angers Universitary Hospital Recruiting
Angers, France, 49933
Contact: Pierre PiAbgueguen, PH       PiAbgueguen@chu-angers.fr   
Principal Investigator: Pierre ABGUEGUEN, PH         
La Roche/Yon hospital Recruiting
La Roche/Yon, France, 85925
Contact: Thomas GUIMARD, PH       thomas.guimard@chd-vendee.fr   
Principal Investigator: Thomas GUIMARD, PH         
Poitiers Universitary hospital Recruiting
Poitiers, France, 86021
Contact: France ROBLOT, PU-PH       f.roblot@chu-poitiers.fr   
Principal Investigator: France ROBLOT, PU-PH         
Rennes Universitary hospital Recruiting
Rennes, France, 35033
Contact: Pierre TATTEVIN, PH    +33 2 99 28 43 21    pierre.tattevin@chu-rennes.fr   
Principal Investigator: Pierre TATTEVIN, PH         
St Nazaire hospital Recruiting
St Nazaire, France, 44600
Contact: Jérôme HOFF, PH       j.hoff@ch-saintnazaire.fr   
Principal Investigator: Jérôme HOFF, PH         
Tours universitary hospital Recruiting
Tours, France, 37170
Contact: Louis BERNARD, PU-PH       garot@med.univ-tours.fr   
Principal Investigator: Louis BERNARD, PU-PH         
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01745679     History of Changes
Other Study ID Numbers: RC12-0171
Study First Received: December 4, 2012
Last Updated: December 10, 2012
Health Authority: France:ANSM

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

Additional relevant MeSH terms:
Meningitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014