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Pharmacological Study of High Doses of Ceftriaxone in Meningitidis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01745679
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE December 4, 2012
First Posted Date  ICMJE December 10, 2012
Last Update Posted Date October 5, 2016
Study Start Date  ICMJE December 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01745679 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacological Study of High Doses of Ceftriaxone in Meningitidis
Official Title  ICMJE Therapeutic Monitoring of Ceftriaxone, Prescribed at High Doses, in the Treatment of Meningitis and Others Neurological Infections.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Meningitis
  • Neurological Infections
Intervention  ICMJE Drug: Ceftriaxone treatment
ceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day
Study Arms  ICMJE Experimental: Ceftriaxone treatment
ceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day
Intervention: Drug: Ceftriaxone treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2016)
198
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2012)
200
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01745679
Other Study ID Numbers  ICMJE RC12_0171
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nantes University Hospital
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP