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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 troubles

clinical 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

Page last updated: August 23, 2015

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