NCT01059890

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

3.8 years

First QC Date

January 29, 2010

Last Update Submit

October 10, 2016

Conditions

Bacterial InfectionBrain Injury

Study Arms (4)

Cefotaxime

EXPERIMENTAL
Drug: cefotaxime

Metrodinazole

EXPERIMENTAL
Drug: Metronidazole

Ciprofloxacine

EXPERIMENTAL
Drug: Ciprofloxacin

Fosfocine

EXPERIMENTAL
Drug: Fosfocine

Interventions

cefotaximeDRUG
Cefotaxime
MetronidazoleDRUG
Metrodinazole
CiprofloxacinDRUG
Ciprofloxacine
FosfocineDRUG
Fosfocine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Bacterial InfectionsBrain Injuries

Interventions

CefotaximeMetronidazoleCiprofloxacin

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

CephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingFluoroquinolones4-QuinolonesQuinolonesQuinolines

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2010

First Posted

February 1, 2010

Study Start

September 1, 2009

Primary Completion

June 1, 2013

Last Updated

October 11, 2016

Record last verified: 2016-10

Locations

FR(1)