Back to resultsPharmacological Study of High Doses of Ceftriaxone in Meningitidis
Primary Purpose
Meningitis, Neurological Infections
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Ceftriaxone treatment
Sponsored by
About this trial
This is an interventional health services research trial for Meningitis focused on measuring Ceftriaxone, Adverse drug effects, Therapeutic monitoring, Meningitis
Eligibility 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
Sites / Locations
- Nantes Universitary Hospital
- Angers Universitary Hospital
- La Roche/Yon hospital
- Poitiers Universitary hospital
- Rennes Universitary hospital
- St Nazaire hospital
- Tours universitary hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ceftriaxone treatment
Arm Description
ceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day
Outcomes
Primary Outcome Measures
plasmatic concentration of ceftriaxone, measured at the steady state (after 48 hours of treatment at least).
Secondary Outcome Measures
Neurological troubles
Neurological troubles explored by electroencephalogram aiming to diagnose epileptic syndrome.
clinical evolution
Time of return to apyrexia, health complications and lenght of hospital stay will be registered.
Full Information
NCT ID
NCT01745679
First Posted
December 4, 2012
Last Updated
October 4, 2016
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01745679
Brief Title
Pharmacological Study of High Doses of Ceftriaxone in Meningitidis
Official Title
Therapeutic Monitoring of Ceftriaxone, Prescribed at High Doses, in the Treatment of Meningitis and Others Neurological Infections.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Neurological Infections
Keywords
Ceftriaxone, Adverse drug effects, Therapeutic monitoring, Meningitis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ceftriaxone treatment
Arm Type
Experimental
Arm Description
ceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone treatment
Intervention Description
ceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Neurological troubles
Description
Neurological troubles explored by electroencephalogram aiming to diagnose epileptic syndrome.
Time Frame
participants will be followed for the duration of ceftriaxone treatment, an expected average of two weeks
Title
clinical evolution
Description
Time of return to apyrexia, health complications and lenght of hospital stay will be registered.
Time Frame
participants will be followed for the duration of ceftriaxone treatment, an expected average of 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Nantes Universitary Hospital
City
Nantes
State/Province
Loire Atlantique
ZIP/Postal Code
44093
Country
France
Facility Name
Angers Universitary Hospital
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
La Roche/Yon hospital
City
La Roche/Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Poitiers Universitary hospital
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Rennes Universitary hospital
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
St Nazaire hospital
City
St Nazaire
ZIP/Postal Code
44600
Country
France
Facility Name
Tours universitary hospital
City
Tours
ZIP/Postal Code
37170
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
31235630
Citation
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.
Results Reference
derived
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Pharmacological Study of High Doses of Ceftriaxone in Meningitidis
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