Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With External Ventricular Drainage
NCT ID: NCT06119061
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
20 participants
INTERVENTIONAL
2024-07-02
2026-12-31
Brief Summary
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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.
Detailed Description
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Methods: 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. Patients will be excluded if they have a history of telavancin or similar agents, reduced renal function (estimated creatinine clearance \< 50ml/min) at the time of consent, severe anemia (hemoglobin \< 7gm/dl), vulnerable population (pregnant, prisoner).
Subjects will receive telavancin 10mg/kg (maximum 1000mg) every 24 hours for 3 consecutive doses. Baseline serum and CSF samples will be drawn before the initial dose of telavancin. Serial serum and CSF samples will be obtained after the first and third doses (1, 3, 6, 23 hours after infusion). A terminal concentration will also be obtained approximately 48 hours after the last dose. An 8-hour urine collection will be completed on study day 2 in order to define the patient's measured creatinine clearance.
Major Goals Goal 1. Determine the CNS penetration of telavancin in critically ill patients with SAH. Serial CSF and serum samples will be obtained from SAH patients with EVDs before and after scheduled telavancin doses in order to determine the degree of CNS penetration of telavancin.
Goal 2. Describe the pharmacokinetics of telavancin in critically ill patients with SAH. Patients with SAH frequently exhibit augmented renal clearance.(5) This increase in renal clearance has been demonstrated to affect the pharmacokinetics of numerous renally-eliminated medications. Volume of distribution may also be affected for many medications (such as telavancin) due to the frequent aggressive measures needed to maintain euvolemia or hypervolemia in some instances (due to SAH-induced vasospasm) and changes in serum albumin concentrations.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Telavancin
Subjects receiving telavancin for pharmacokinetic sampling
Telavancin Injection
Telavancin 10mg/kg (maximum 1000mg) administered intravenously over 60 minutes (through a central venous catheter whenever available).
Interventions
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Telavancin Injection
Telavancin 10mg/kg (maximum 1000mg) administered intravenously over 60 minutes (through a central venous catheter whenever available).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Actively draining ventriculostomy
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Cumberland Pharmaceuticals
INDUSTRY
Aaron Cook
OTHER
Responsible Party
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Aaron Cook
Professor
Principal Investigators
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Aaron M Cook, PharmD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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University of Kentucky
Lexington, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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Aaron M Cook, PharmD
Role: primary
References
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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.
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.
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.
Cook AM, Hatton-Kolpek J. Augmented Renal Clearance. Pharmacotherapy. 2019 Mar;39(3):346-354. doi: 10.1002/phar.2231. Epub 2019 Mar 11.
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.
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.
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.
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.
Other Identifiers
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84795
Identifier Type: -
Identifier Source: org_study_id