Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection

Neurosurgery Clinical Trial

Official title:

Antibiotics in Cerebrospinal Fluid Following Intravenous Injection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00925093
• Other study ID #: AUH-MGP-AB-CSV-2009-1
• Status: Withdrawn
• Phase: Phase 1
• First received: June 18, 2009
• Last updated: January 23, 2015
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: June 2009
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

Three different antibiotics are used to prevent infection in case of neurosurgery - this study examines to which extent the antibiotics penetrate from the blood to the cerebrospinal fluid (surrounding the brain).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years old

• Already having an external CSF drain

• Scheduled for neurosurgery requiring antibiotic prophylaxis (most commonly placement of an internal drain ("shunt")

Exclusion Criteria:

• Infection or colonization requiring other than standard prophylactic antibiotics

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neurosurgery

Intervention

Drug:
• Vancomycin
Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample
• Teicoplanin
Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample
• Linezolid
Linezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of antibiotics in cerebrospinal fluid	Concentration in CSF past i.v. injection	1, 2, 4, 6, 12 hours	No