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NCT00925093 Clinical Trial

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Clinical Trial Details — Status: Withdrawn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
Secondary ID
Status Withdrawn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Status Withdrawn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

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
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