About this trial
The proposed study aims to evaluate the CNS penetration of telavancin in a critically ill population using cerebrospinal fluid (CSF) drawn from external ventricular drains (EVDs). Patients with EVDs were chosen as the target population because they frequently require prolonged admission to the intensive care unit and drainage of CSF in order to prevent hydrocephalus. The estimated sample size is 20 subjects. This is a prospective cohort of patients with SAH. Patients will be included if they have an in-dwelling EVD, aged 18-85 years old.
Subjects will receive telavancin 10mg/kg (maximum 1000mg) every 24 hours for 3 consecutive doses. Serial serum and CSF samples will be obtained. An 8-hour urine collection will be completed on study day 2 in order to define the patient's measured creatinine clearance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult aged 18-85 years
Actively draining ventriculostomy
Disqualifiers
history of hypersensitivity to telavancin or similar agents
reduced renal function (estimated creatinine clearance < 50/ml) at the time of consent
severe anemia (hemoglobin < 7gm/dl)
vulnerable population (pregnant, prisoner)
Trial design
Single group
Treatments tested in this trial
Telavancin Injection
DrugTelavancin 10mg/kg (maximum 1000mg) administered intravenously over 60 minutes (through a central venous catheter whenever available).
Treatment groups
Trial outcomes
Primary outcomes
Determine the CNS penetration of telavancin in critically ill patients with External Ventricular Drainage
Telavancin concentrations in CSF drawn from external ventricular drains will be compared to samples from the serum to determine the degree to which telavancin is present in the CNS
Secondary outcomes
Describe the pharmacokinetics of telavancin in critically ill patients with External Ventricular Drainage
Analyze serial serum concentrations of telavancin to determine the population's clearance, half-life, \& volume of distribution
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aaron Cook
Lead sponsor
University of Kentucky
Sponsor institution
Cumberland Pharmaceuticals
Collaborator