Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 10:11 PM
Study NCT ID:
NCT06119061
Status:
RECRUITING
Last Update Posted:
2025-04-18
First Post:
2023-10-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C487637', 'term': 'telavancin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2023-10-31', 'studyFirstSubmitQcDate': '2023-10-31', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the CNS penetration of telavancin in critically ill patients with SAH', 'timeFrame': '3 days', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Describe the pharmacokinetics of telavancin in critically ill patients with SAH', 'timeFrame': '5 days', 'description': "Analyze serial serum concentrations of telavancin to determine the population's clearance, half-life, \\& volume of distribution"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'augmented renal clearance'], 'conditions': ['Subarachnoid Hemorrhage, Aneurysmal']}, 'referencesModule': {'references': [{'pmid': '28203777', 'type': 'BACKGROUND', 'citation': "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': '21612470', 'type': 'BACKGROUND', 'citation': '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': '10770777', 'type': 'BACKGROUND', 'citation': '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': '32658968', 'type': 'BACKGROUND', 'citation': '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': '16436742', 'type': 'BACKGROUND', 'citation': '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': '30723936', 'type': 'BACKGROUND', 'citation': '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': '28756331', 'type': 'BACKGROUND', 'citation': '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': '15616296', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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) in patients who have had spontaneous subarachnoid hemorrhage (SAH). Patients with SAH 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 a spontaneous SAH, aged 18-65 years old, Hunt-Hess score of 1-4 \\& has an actively draining ventriculostomy.\n\nSubjects 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.", 'detailedDescription': "Telavancin exhibits potent and durable activity against target pathogens for bacterial meningitis and ventriculitis. There is a potential role for telavancin in treating Gram positive CNS pathogens, particularly in patients with resistant pathogens or in those who are intolerant to other commonly used antimicrobials. 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) in patients who have had spontaneous subarachnoid hemorrhage (SAH). Patients with SAH 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 15 subjects.\n\nMethods: 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).\n\nSubjects 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.\n\nMajor 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.\n\nGoal 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spontaneous subarachnoid hemorrhage\n* Hunt-Hess score of 1-4\n* Actively draining ventriculostomy\n\nExclusion Criteria:\n\n* history of hypersensitivity to telavancin or similar agents\n* reduced renal function (estimated creatinine clearance \\< 50/ml) at the time of consent\n* severe anemia (hemoglobin \\< 7gm/dl)\n* vulnerable population (pregnant, prisoner)'}, 'identificationModule': {'nctId': 'NCT06119061', 'briefTitle': 'Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': '84795'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telavancin', 'description': 'Subjects receiving telavancin for pharmacokinetic sampling', 'interventionNames': ['Drug: Telavancin Injection']}], 'interventions': [{'name': 'Telavancin Injection', 'type': 'DRUG', 'otherNames': ['Vibativ'], 'description': 'Telavancin 10mg/kg (maximum 1000mg) administered intravenously over 60 minutes (through a central venous catheter whenever available).', 'armGroupLabels': ['Telavancin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aaron M Cook, PharmD', 'role': 'CONTACT', 'email': 'amcook0@email.uky.edu', 'phone': '859-323-9258'}, {'name': 'David Burgess, PharmD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David Dornbos, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Justin Fraser, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kevin Hatton, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ryan Mynatt, PharmD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'centralContacts': [{'name': 'Aaron Cook, PharmD', 'role': 'CONTACT', 'email': 'amcook0@email.uky.edu', 'phone': '859-323-9258'}], 'overallOfficials': [{'name': 'Aaron M Cook, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'Data from this study may be requested from other researchers 2 years after the completion of the primary endpoint by contacting the primary investigator', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aaron Cook', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cumberland Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Aaron Cook', 'investigatorAffiliation': 'University of Kentucky'}}}}