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

NCT06119061 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-26

No results posted yet for this study

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

Interventions

DRUG

Telavancin Injection

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

Sponsors & Collaborators

  • Cumberland Pharmaceuticals

    collaborator INDUSTRY

  • Aaron Cook

    lead OTHER

Principal Investigators

  • Aaron M Cook, PharmD · University of Kentucky

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-02
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06119061 on ClinicalTrials.gov