Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With External Ventricular Drainage

NCT06119061 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 84795
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Keywords

pharmacokinetics; augmented renal clearance

Outcome Measures

Primary Outcomes (1)

• Determine the CNS penetration of telavancin in critically ill patients with External Ventricular Drainage

  Telavancin concentrations in CSF drawn from external ventricular drains will be compared to samples from the serum to determine the degree to which telavancin is present in the CNS

  3 days

Secondary Outcomes (1)

• Describe the pharmacokinetics of telavancin in critically ill patients with External Ventricular Drainage

  5 days

Study Arms (1)

Telavancin

EXPERIMENTAL

Subjects receiving telavancin for pharmacokinetic sampling

Drug: Telavancin Injection

Interventions

Telavancin Injection DRUG

Telavancin 10mg/kg (maximum 1000mg) administered intravenously over 60 minutes (through a central venous catheter whenever available).

Also known as: Vibativ

Telavancin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult aged 18-85 years
• Actively draining ventriculostomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Aaron Cook: lead
• Cumberland Pharmaceuticals: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Related Publications (8)

• Tunkel AR, Hasbun R, Bhimraj A, Byers K, Kaplan SL, Scheld WM, van de Beek D, Bleck TP, Garton HJL, Zunt JR. 2017 Infectious Diseases Society of America's Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis. Clin Infect Dis. 2017 Mar 15;64(6):e34-e65. doi: 10.1093/cid/ciw861.

  PMID: 28203777 BACKGROUND

• Thigpen MC, Whitney CG, Messonnier NE, Zell ER, Lynfield R, Hadler JL, Harrison LH, Farley MM, Reingold A, Bennett NM, Craig AS, Schaffner W, Thomas A, Lewis MM, Scallan E, Schuchat A; Emerging Infections Programs Network. Bacterial meningitis in the United States, 1998-2007. N Engl J Med. 2011 May 26;364(21):2016-25. doi: 10.1056/NEJMoa1005384.

  PMID: 21612470 BACKGROUND

• Rybak MJ, Le J, Lodise TP, Levine DP, Bradley JS, Liu C, Mueller BA, Pai MP, Wong-Beringer A, Rotschafer JC, Rodvold KA, Maples HD, Lomaestro B. Therapeutic Monitoring of Vancomycin for Serious Methicillin-resistant Staphylococcus aureus Infections: A Revised Consensus Guideline and Review by the American Society of Health-system Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. Clin Infect Dis. 2020 Sep 12;71(6):1361-1364. doi: 10.1093/cid/ciaa303.

  PMID: 32658968 BACKGROUND

• Cook AM, Hatton-Kolpek J. Augmented Renal Clearance. Pharmacotherapy. 2019 Mar;39(3):346-354. doi: 10.1002/phar.2231. Epub 2019 Mar 11.

  PMID: 30723936 BACKGROUND

• Carrie C, Bentejac M, Cottenceau V, Masson F, Petit L, Cochard JF, Sztark F. Association between augmented renal clearance and clinical failure of antibiotic treatment in brain-injured patients with ventilator-acquired pneumonia: A preliminary study. Anaesth Crit Care Pain Med. 2018 Feb;37(1):35-41. doi: 10.1016/j.accpm.2017.06.006. Epub 2017 Jul 26.

  PMID: 28756331 BACKGROUND

• Shaw JP, Seroogy J, Kaniga K, Higgins DL, Kitt M, Barriere S. Pharmacokinetics, serum inhibitory and bactericidal activity, and safety of telavancin in healthy subjects. Antimicrob Agents Chemother. 2005 Jan;49(1):195-201. doi: 10.1128/AAC.49.1.195-201.2005.

  PMID: 15616296 BACKGROUND

• Albanese J, Leone M, Bruguerolle B, Ayem ML, Lacarelle B, Martin C. Cerebrospinal fluid penetration and pharmacokinetics of vancomycin administered by continuous infusion to mechanically ventilated patients in an intensive care unit. Antimicrob Agents Chemother. 2000 May;44(5):1356-8. doi: 10.1128/AAC.44.5.1356-1358.2000.

  PMID: 10770777 RESULT

• Stucki A, Gerber P, Acosta F, Cottagnoud M, Cottagnoud P. Efficacy of telavancin against penicillin-resistant pneumococci and Staphylococcus aureus in a rabbit meningitis model and determination of kinetic parameters. Antimicrob Agents Chemother. 2006 Feb;50(2):770-3. doi: 10.1128/AAC.50.2.770-773.2006.

  PMID: 16436742 RESULT

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

telavancin

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aaron M Cook, PharmD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron Cook, PharmD

CONTACT

859-323-9258; amcook0@email.uky.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: July 2, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data from this study may be requested from other researchers 2 years after the completion of the primary endpoint by contacting the primary investigator

Locations

US (1)