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.
1 other identifier
interventional
198
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2012
Typical duration for phase_4
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 4, 2012
CompletedFirst Posted
Study publicly available on registry
December 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedOctober 5, 2016
October 1, 2016
3 years
December 4, 2012
October 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Neurological troubles
participants will be followed for the duration of ceftriaxone treatment, an expected average of two weeks
clinical evolution
participants will be followed for the duration of ceftriaxone treatment, an expected average of 2 weeks
Study Arms (1)
Ceftriaxone treatment
EXPERIMENTALceftriaxone will be administered à high dose : \> or equal to 75mg/kg/day or 4 gr/day
Interventions
ceftriaxone will be administered à high dose : \> or equal to 75mg/kg/day or 4 gr/day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- Patient under guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Tours universitary hospital
Tours, France, 37170, France
Nantes Universitary Hospital
Nantes, Loire Atlantique, 44093, France
Angers Universitary Hospital
Angers, 49933, France
La Roche/Yon hospital
La Roche/Yon, 85925, France
Poitiers Universitary hospital
Poitiers, 86021, France
Rennes Universitary hospital
Rennes, 35033, France
St Nazaire hospital
Saint-Nazaire, 44600, France
Related Publications (1)
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.
PMID: 31235630DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2012
First Posted
December 10, 2012
Study Start
December 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
October 5, 2016
Record last verified: 2016-10