RecruitingPhase 4NCT06119061

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


Sponsor

Aaron Cook

Enrollment

20 participants

Start Date

Jul 2, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria2

  • Adult aged 18-85 years
  • Actively draining ventriculostomy

Exclusion Criteria5

  • 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

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Interventions

DRUGTelavancin Injection

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


Locations(1)

University of Kentucky

Lexington, Kentucky, United States

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NCT06119061


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