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Cerebral Antibiotics Distribution After Acute Brain Injury

Primary Purpose

Bacterial Infection, Brain Injury

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
cefotaxime
Metronidazole
Ciprofloxacin
Fosfocine
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Bacterial Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute brain injury
  • Patient who receive an antibiotic for an infection or prophylaxy
  • Glasgow coma score < 8

Exclusion Criteria:

  • Age < 18 years old
  • Pregnant woman
  • HCV, HIV, HBV infection

Sites / Locations

  • Poitiers University Hospital - 2 rue de la Milétrie - Réanimation chirugicale

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cefotaxime

Metrodinazole

Ciprofloxacine

Fosfocine

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 29, 2010
Last Updated
October 10, 2016
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01059890
Brief Title
Cerebral Antibiotics Distribution After Acute Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Poitiers University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to explore the distribution of antibiotics in the brain after an acute brain injury because brain infections treatment is still an health care problem.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infection, Brain Injury

7. Study Design

Study Phase
Phase 1
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cefotaxime
Arm Type
Experimental
Arm Title
Metrodinazole
Arm Type
Experimental
Arm Title
Ciprofloxacine
Arm Type
Experimental
Arm Title
Fosfocine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
cefotaxime
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Intervention Type
Drug
Intervention Name(s)
Fosfocine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute brain injury Patient who receive an antibiotic for an infection or prophylaxy Glasgow coma score < 8 Exclusion Criteria: Age < 18 years old Pregnant woman HCV, HIV, HBV infection
Facility Information:
Facility Name
Poitiers University Hospital - 2 rue de la Milétrie - Réanimation chirugicale
City
Poitiers
ZIP/Postal Code
86021
Country
France

12. IPD Sharing Statement

Learn more about this trial

Cerebral Antibiotics Distribution After Acute Brain Injury

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