Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With Subarachnoid Hemorrhage

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Spontaneous subarachnoid hemorrhage

• Hunt-Hess score of 1-4

• Actively draining ventriculostomy

Locations
United States
Kentucky
University of Kentucky
RECRUITING
Lexington
Contact Information
Primary
Aaron Cook, PharmD
amcook0@email.uky.edu
859-323-9258
Time Frame
Start Date: 2024-07-02
Estimated Completion Date: 2026-01
Participants
Target number of participants: 20
Treatments
Experimental: Telavancin
Subjects receiving telavancin for pharmacokinetic sampling
Related Therapeutic Areas
Sponsors
Collaborators: Cumberland Pharmaceuticals
Leads: Aaron Cook

This content was sourced from clinicaltrials.gov