Pharmacological Study of High Doses of Ceftriaxone in Meningitidis
Information source: Nantes University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Meningitis; Neurological Infections
Intervention: Ceftriaxone treatment (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Nantes University Hospital Overall contact: Nathalie ASSERAY, PH, Phone: +33 2 40 08 33 16, Email: nasseray@chu-nantes.fr
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.
Clinical Details
Official title: Therapeutic Monitoring of Ceftriaxone, Prescribed at High Doses, in the Treatment of Meningitis and Others Neurological Infections.
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Primary outcome: plasmatic concentration of ceftriaxone, measured at the steady state (after 48 hours of treatment at least).
Secondary outcome: Neurological troublesclinical evolution
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Nathalie ASSERAY, PH, Phone: +33 2 40 08 33 16, Email: nasseray@chu-nantes.fr
Angers Universitary Hospital, Angers 49933, France; Recruiting Pierre PiAbgueguen, PH, Email: PiAbgueguen@chu-angers.fr Pierre ABGUEGUEN, PH, Principal Investigator
La Roche/Yon hospital, La Roche/Yon 85925, France; Recruiting Thomas GUIMARD, PH, Email: thomas.guimard@chd-vendee.fr Thomas GUIMARD, PH, Principal Investigator
Poitiers Universitary hospital, Poitiers 86021, France; Recruiting France ROBLOT, PU-PH, Email: f.roblot@chu-poitiers.fr France ROBLOT, PU-PH, Principal Investigator
Rennes Universitary hospital, Rennes 35033, France; Recruiting Pierre TATTEVIN, PH, Phone: +33 2 99 28 43 21, Email: pierre.tattevin@chu-rennes.fr Pierre TATTEVIN, PH, Principal Investigator
St Nazaire hospital, St Nazaire 44600, France; Recruiting Jérôme HOFF, PH, Email: j.hoff@ch-saintnazaire.fr Jérôme HOFF, PH, Principal Investigator
Tours universitary hospital, Tours 37170, France; Recruiting Louis BERNARD, PU-PH, Email: garot@med.univ-tours.fr Louis BERNARD, PU-PH, Principal Investigator
Nantes Universitary Hospital, Nantes, Loire Atlantique 44093, France; Recruiting Nathalie ASSERAY, PH, Phone: +33 2 40 08 33 16, Email: nasseray@chu-nantes.fr Nathalie ASSERAY, PH, Principal Investigator
Additional Information
Starting date: December 2012
Last updated: January 28, 2015
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