Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With Subarachnoid Hemorrhage

• Status: Recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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) in patients who have had spontaneous subarachnoid hemorrhage (SAH). Patients with SAH 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 a spontaneous SAH, aged 18-65 years old, Hunt-Hess score of 1-4 & has an actively draining ventriculostomy.

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aaron Cook
• Collaborator: Cumberland Pharmaceuticals
• Treatments: Telavancin

Criteria

Inclusion Criteria:

• Spontaneous subarachnoid hemorrhage

• Hunt-Hess score of 1-4

• Actively draining ventriculostomy

Exclusion Criteria:

• 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)