Telavancin for Subarachnoid Hemorrhage

Overseen By Aaron Cook, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Aaron Cook

Disqualifiers: Hypersensitivity to telavancin, Reduced renal function, Severe anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 days

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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) in patients who have had spontaneous subarachnoid hemorrhage (SAH). Patients with SAH 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 a spontaneous SAH, aged 18-65 years old, Hunt-Hess score of 1-4 \& has an actively draining ventriculostomy. 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Aaron M Cook, PharmD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for adults aged 18-65 with spontaneous subarachnoid hemorrhage, a condition where bleeding occurs between the brain and surrounding tissues. Participants must have a Hunt-Hess score of 1-4, indicating varying levels of severity but not deep coma, and an actively draining ventriculostomy. Those with allergies to telavancin or similar drugs, poor kidney function, severe anemia, or who are pregnant or imprisoned cannot join.

Inclusion Criteria

I have had a bleeding in the space around my brain.

You have a ventriculostomy that is currently draining.

My Hunt-Hess score is between 1 and 4.

Exclusion Criteria

You have had a bad reaction to telavancin or similar medications in the past.

Vulnerable population (pregnant, prisoner)

My kidney function is reduced with a creatinine clearance below 50 ml/min.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Subjects receive telavancin 10mg/kg every 24 hours for 3 consecutive doses with serial serum and CSF sampling

3 days

Daily visits for dosing and sampling

Pharmacokinetic Analysis

Analyze serial serum concentrations of telavancin to determine pharmacokinetics

5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Telavancin

Trial Overview The study tests how well telavancin penetrates into the cerebrospinal fluid (CSF) in patients with subarachnoid hemorrhage. Twenty participants will receive three doses of telavancin at 10mg/kg every 24 hours. Researchers will collect blood and CSF samples periodically to measure drug concentrations.

Participant Groups

Group I: Telavancin Experimental Treatment 1 Intervention

Subjects receiving telavancin for pharmacokinetic sampling

Telavancin is already approved in United States, European Union for the following indications:

Approved in United States as Vibativ for:

• Complicated skin and skin structure infections
• Hospital-acquired and ventilator-associated bacterial pneumonia

Approved in European Union as Vibativ for:

• Nosocomial pneumonia (hospital-acquired), including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA) when other alternatives are not suitable

Who Is Running the Clinical Trial?

Aaron Cook

Lead Sponsor

Trials

2

Recruited

80+

Cumberland Pharmaceuticals

Industry Sponsor

Trials

63

Recruited

9,400+

A.J. Kazimi

Cumberland Pharmaceuticals

Chief Executive Officer since 1999

B.S. from the University of Notre Dame, MBA from Vanderbilt University Owen Graduate School of Management

Ines Macias-Perez

Cumberland Pharmaceuticals

Chief Medical Officer

Ph.D. in Cancer Biology from Vanderbilt University