Recruiting

Telavancin

Sponsor:

Aaron Cook

Code:

NCT06119061

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Telavancin Injection

Study Details

Brief 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). 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.

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Study ID

NCT06119061

Start date

Jul 2, 2024

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult aged 18-85 years
  • 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)
  • concomitant antimicrobial therapy

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Telavancin

Subjects receiving telavancin for pharmacokinetic sampling

Interventions

Telavancin Injection

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Aaron Cook, PharmD

859-323-9258amcook0@email.uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Aaron M Cook, PharmD

859-323-9258amcook0@email.uky.edu

More Information

Sponsor

Aaron Cook

Last update posted

Dec 26, 2025

Last verified

Dec, 2025

Keywords

  • pharmacokinetics
  • augmented renal clearance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Aaron Cook on 2025-12-26.