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Antibiotic

Telavancin for Subarachnoid Hemorrhage

Phase 4
Recruiting
Led By Aaron M Cook, PharmD
Research Sponsored by Aaron Cook
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Spontaneous subarachnoid hemorrhage
Hunt-Hess score of 1-4
Must not have
Reduced renal function (estimated creatinine clearance < 50/ml) at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will evaluate the CNS penetration of telavancin in patients with SAH who require ventriculostomy. It will measure drug concentrations in serum & CSF, as well as creatinine clearance.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Telavancin may cause side effects such as changes in taste sensation, nausea, vomiting, foamy urine (indicating proteinuria), dizziness upon standing up too fast (orthostatic hypotension), and increased risk for new infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a bleeding in the space around my brain.
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My Hunt-Hess score is between 1 and 4.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is reduced with a creatinine clearance below 50 ml/min.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the CNS penetration of telavancin in critically ill patients with SAH
Secondary study objectives
Describe the pharmacokinetics of telavancin in critically ill patients with SAH

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TelavancinExperimental Treatment1 Intervention
Subjects receiving telavancin for pharmacokinetic sampling
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telavancin Injection
2017
Completed Phase 4
~20

Find a Location

Who is running the clinical trial?

Aaron CookLead Sponsor
1 Previous Clinical Trials
56 Total Patients Enrolled
Cumberland PharmaceuticalsIndustry Sponsor
62 Previous Clinical Trials
9,421 Total Patients Enrolled
Aaron M Cook, PharmDPrincipal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
56 Total Patients Enrolled
~11 spots leftby Dec 2025
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