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CompletedNCT01059890Updated Oct 11, 2016

Cerebral Antibiotics Distribution After Acute Brain Injury

A Phase 1 interventional study of cefotaxime and Metronidazole in Bacterial Infection and Brain Injury, sponsored by Poitiers University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-11.

Sponsored by Poitiers University Hospital · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
18
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bacterial Infection
  • Brain Injury
03

In context

Bacterial Infections

658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.

This study's enrollment of 18 is below the median of 84 across 405 interventional studies indexed under Bacterial Infections.

Browse Bacterial Infections studies →

Lead sponsor

Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years old
  • Pregnant woman
  • HCV, HIV, HBV infection
05

Study design

Phase
Phase 1
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Cefotaxime

    Drug: cefotaxime

  • Experimental
    Metrodinazole

    Drug: Metronidazole

  • Experimental
    Ciprofloxacine

    Drug: Ciprofloxacin

  • Experimental
    Fosfocine

    Drug: Fosfocine

Interventions

  • Drugcefotaxime
  • DrugMetronidazole
  • DrugCiprofloxacin
  • DrugFosfocine
06

Study locations

1 site
  • Poitiers University Hospital - 2 rue de la Milétrie - Réanimation chirugicale
    Poitiers, 86021, France
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01059890
Lead sponsor
Poitiers University Hospital
First posted
Feb 1, 2010
Start date
Sep 2009
Primary completion
Jun 2013
Last update
Oct 11, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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