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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine the CNS penetration of telavancin in critically ill patients with SAH

Secondary outcome measures

Describe the pharmacokinetics of telavancin in critically ill patients with SAH

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT02392208

13%

New onset atrial flutter

100%

80%

60%

40%

20%

Study treatment Arm

Telavancin Before Hemodialysis

Telavancin After Hemodialysis

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Aaron CookLead Sponsor

Cumberland PharmaceuticalsIndustry Sponsor

62 Previous Clinical Trials

9,443 Total Patients Enrolled

Aaron M Cook, PharmDPrincipal InvestigatorUniversity of Kentucky

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors eligible to be enrolled in this clinical trial?

"Eligibility for this study is contingent on being between 18 and 65 years old."

Answered by AI

Is it possible for me to enroll in this clinical experiment?

"This clinical trial, which is accepting up to 20 participants, requires that applicants have a brain aneurysm and be between 18-65 years of age."

Answered by AI

Has the Food & Drug Administration greenlit Telavancin for use?

"The team at Power assigned Telavancin a safety score of 3, as this is an FDA-approved Phase 4 trial."

Answered by AI

Are there any remaining vacancies for participants in this research project?

"Clinicaltrials.gov reveals that this medical trial has ceased recruiting patients, with its first posting on November 1st 2023 and last update made the following month. Despite no longer requiring participants, there are 373 other studies actively searching for volunteers currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With Subarachnoid Hemorrhage

Aaron Cook 2024. "Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With Subarachnoid Hemorrhage". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06119061.

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