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Completed

NCT Number: NCT01745679

Pharmacological Study of High Doses of Ceftriaxone in Meningitidis

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.

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Key information

Conditions

Meningitis Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Nervous System Diseases Neuroinflammatory Diseases Neurological Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tours universitary hospital, Tours, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ceftriaxone treatment

Drug

ceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day

Primary outcomes

  1. 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 outcomes

  1. Neurological troubles

    Time frame: participants will be followed for the duration of ceftriaxone treatment, an expected average of two weeks

    Neurological troubles explored by electroencephalogram aiming to diagnose epileptic syndrome.

  2. clinical evolution

    Time frame: participants will be followed for the duration of ceftriaxone treatment, an expected average of 2 weeks

    Time of return to apyrexia, health complications and lenght of hospital stay will be registered.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Therapeutic Monitoring of Ceftriaxone, Prescribed at High Doses, in the Treatment of Meningitis and Others Neurological Infections.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 10, 2012
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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