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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well the drug telavancin penetrates the brain's fluid to aid individuals with subarachnoid hemorrhage (SAH), a specific type of brain bleeding. The focus is on seriously ill patients who require special draining tubes in their brains to prevent complications. Researchers aim to understand telavancin's behavior in this context, which might assist in treating similar conditions in the future. This trial suits individuals who have experienced a spontaneous SAH, meet certain health criteria, and use a brain fluid drain. As a Phase 4 trial, the research seeks to understand how this already FDA-approved and effective treatment can benefit more patients.

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.

What is the safety track record for telavancin?

Research shows that telavancin is generally well-tolerated, meaning most people can handle its side effects. Studies have demonstrated its safety for treating various conditions. In real-world use, taking telavancin once a day has been safe for treating different bacterial infections.

The FDA approved telavancin in 2009 for certain infections, indicating it has undergone thorough testing to ensure safety for use.

This study tests telavancin in patients with subarachnoid hemorrhage, a type of brain bleed. As a Phase 4 study, telavancin has already shown safety in earlier trials and is now tested in larger groups or for new uses. While side effects can still occur, telavancin has a history of being well-tolerated. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for subarachnoid hemorrhage, which typically focus on managing symptoms and complications, telavancin is being explored for its potential pharmacokinetic properties in this condition. Researchers are excited about telavancin because it is usually known as an antibiotic, suggesting it might have unique effects or benefits in the brain that are not yet fully understood, especially in the context of hemorrhagic conditions. This treatment could offer a new approach by possibly addressing underlying issues differently than current therapies, sparking hope for improved outcomes.

What evidence suggests that telavancin might be an effective treatment for subarachnoid hemorrhage?

Research has shown that telavancin works well against bacterial infections, especially challenging ones like MRSA, a type of bacteria resistant to many antibiotics. It has demonstrated high success rates in curing serious infections. In this trial, participants will receive telavancin to determine whether it can reach the brain's fluid, which is crucial for treating brain infections. Although telavancin is not yet proven for treating bleeding in the brain (subarachnoid hemorrhage or SAH), the study aims to discover if telavancin can effectively penetrate the cerebrospinal fluid (CSF), potentially aiding in the treatment of conditions requiring strong antibiotics in the brain. ^{1 2 3 4 6}

Who Is on the Research Team?

Aaron M Cook, PharmD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06119061

Telavancin Blood and Cerebrospinal Fluid Concentrations ... The proposed study aims to evaluate the CNS penetration of telavancin in a critically ill population using cerebrospinal fluid (CSF) drawn from external ...

2. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2013/022407Orig1s000MedR.pdf

022407Orig1s000 - accessdata.fda.gov A summary and analysis of maternal and fetal outcomes for all reported pregnancies. (from any data source) including: 1. a cumulative number ...

3. bmcinfectdis.biomedcentral.com bmcinfectdis.biomedcentral.com/articles/10.1186/1471-2334-14-289

A randomized Phase 2 trial of telavancin versus standard ... aureus bacteremia. The primary end point was clinical cure at 84 days. Results. In total, 60 patients were randomized and 58 received ≥1 study ...

4. withpower.com withpower.com/trial/phase-4-subarachnoid-hemorrhage-10-2023-b2e92

Telavancin for Subarachnoid Hemorrhage Trial Overview The study tests how well telavancin penetrates into the cerebrospinal fluid (CSF) in patients with subarachnoid hemorrhage. Twenty participants ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6879699/

Clinical Experience with Telavancin: Real-World Results ... Telavancin has 16- to 32-fold greater activity against MRSA compared with vancomycin [10]. Telavancin demonstrated high cure rates in patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11232409/

Rapid in vitro activity of telavancin against Bacillus ... These results show that post-exposure treatment with telavancin was effective at reducing and resolving the febrile response consistently ...