Clinical trial NCT01745679: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningitis
Neurological Infections
Keywords: Ceftriaxone
Adverse drug effects
Therapeutic monitoring
Meningitis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: plasmatic concentration of ceftriaxone, measured at the steady state (after 48 hours of treatment at least).
timeFrame: after at least 48 hours of ceftriaxone treatment
Secondary outcomes:
measure: Neurological troubles
timeFrame: participants will be followed for the duration of ceftriaxone treatment, an expected average of two weeks
measure: clinical evolution
timeFrame: participants will be followed for the duration of ceftriaxone treatment, an expected average of 2 weeks
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes Universitary Hospital
state: Loire Atlantique
city: Angers
country: France
facility: Angers Universitary Hospital
city: La Roche/Yon
country: France
facility: La Roche/Yon hospital
city: Poitiers
country: France
facility: Poitiers Universitary hospital
city: Rennes
country: France
facility: Rennes Universitary hospital
city: St Nazaire
country: France
facility: St Nazaire hospital
city: Tours
country: France
facility: Tours universitary hospital
Study officials:
References:
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.