Bactericidal External ventricular drainS in paTients with Traumatic Brain Injury

Phase 3

Completed

• Conditions: Traumatic brain injury; Ventriculitis; Injuries and Accidents - Other injuries and accidents; Infection - Other infectious diseases

• Registration Number: ACTRN12614001175662
• Lead Sponsor: The Alfred, Intensive Care Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-07
• Study Completion: 2020-04-06
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

1. Aged at least 16 years old
2. Traumatic brain injury requiring external ventricular drain insertion

Exclusion Criteria

1. Known or suspected CSF infection at time of EVD insertion
2. Any other indication for ongoing antibiotics at the time of EVD insertion
3. Prior EVD insertion (last 30 days)
4. Sepsis, ventriculitis, meningitis, skin infection at implantation site.
5. Allergy to Rifampicin and Clindamycin
6. Multiple EVDs required con-currently

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of central nervous system infections. <br><br>This will be assessed by combined clinical and laboratory analysis of cerebrospinal fluid (CSF), using standard Center for Disease Control criteria to define CSF infection.[At primary hospital discharge]