NCT06119061 Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With External Ventricular Drainage
| NCT ID | NCT06119061 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Aaron Cook |
| Condition | Subarachnoid Hemorrhage, Aneurysmal |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-07-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20 participants in total. It began in 2024-07-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Aaron M Cook, PharmD
PRINCIPAL INVESTIGATOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT06119061 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Subarachnoid Hemorrhage, Aneurysmal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06119061 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06119061 currently recruiting?
Yes, NCT06119061 is actively recruiting participants. Contact the research team at amcook0@email.uky.edu for enrollment information.
Where is the NCT06119061 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT06119061 clinical trial?
NCT06119061 is sponsored by Aaron Cook. The principal investigator is Aaron M Cook, PharmD at University of Kentucky. The trial plans to enroll 20 participants.