Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With External Ventricular Drainage

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAaron Cook

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Telavancin Injection

    Drug

    Telavancin 10mg/kg (maximum 1000mg) administered intravenously over 60 minutes (through a central venous catheter whenever available).

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: TelavancinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
3 days

Secondary outcomes

1

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

Time frame
5 days

Other outcomes

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