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

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Aaron Cook
Study ID
NCT06119061
Phase
PHASE4
Status
Recruiting
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Conditions

  • Subarachnoid Hemorrhage, Aneurysmal

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 2, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Telavancin
    Subjects receiving telavancin for pharmacokinetic sampling

Primary Outcome Measure

Determine the CNS penetration of telavancin in critically ill patients with External Ventricular Drainage [ Time Frame: 3 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40536
Aaron M Cook, PharmD
[email protected]
859-323-9258
David Burgess, PharmD (SUB_INVESTIGATOR)
David Dornbos, MD (SUB_INVESTIGATOR)
Justin Fraser, MD (SUB_INVESTIGATOR)
Kevin Hatton, MD, PhD (SUB_INVESTIGATOR)
Ryan Mynatt, PharmD (SUB_INVESTIGATOR)

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By research site
University of Kentucky· Lexington, KY

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