Cerebral Antibiotics Distribution After Acute Brain Injury | NCT01059890

Studies
Cerebral Antibiotics Distribution After Acute Brain Injury

NCT01059890

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Oct 11, 2016Estimated

Enrollment

18Actual

Phase

Phase 1

Conditions

Bacterial Infection
Brain Injury

Interventions

cefotaxime
Metronidazole
Ciprofloxacin
Fosfocine

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Jun 2013Actual

Completion Date

Not provided

First Submitted Date

Jan 29, 2010

First Submission Date that Met QC Criteria

Jan 29, 2010

First Posted Date

Feb 1, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2016

Last Update Posted Date

Oct 11, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Cefotaxime	Experimental	Drug: cefotaxime
Metrodinazole	Experimental	Drug: Metronidazole
Ciprofloxacine	Experimental	Drug: Ciprofloxacin
Fosfocine	Experimental	Drug: Fosfocine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cefotaxime	Drug		Cefotaxime
Metronidazole

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Poitiers University Hospital - 2 rue de la Milétrie - Réanimation chirugicale		Poitiers		86021	France

Condition Browse Module

MeSH Terms

ID	Term
D001424	Bacterial Infections
D001930	Brain Injuries

Ancestor Terms

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002439	Cefotaxime
D008795	Metronidazole
D002939	Ciprofloxacin

Ancestor Terms

ID	Term
D002505	Cephacetrile
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577

Browse Leaves

Not provided

Browse Branches

Not provided