Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-01-02 @ 1:16 AM
Study NCT ID:
NCT05001750
Status:
RECRUITING
Last Update Posted:
2024-08-15
First Post:
2021-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D058565', 'term': 'Cerebral Ventriculitis'}, {'id': 'D006849', 'term': 'Hydrocephalus'}], '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'}, {'id': 'D020805', 'term': 'Central Nervous System Viral Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009254', 'term': 'Nafcillin'}, {'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients will be randomized into one of two groups, either continuous antibiotic usage until the EVD is removed or antibiotics for a total of twenty-four hours; in both cases antibiotics will begin no more than sixty minutes pre-procedure.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2021-06-25', 'studyFirstSubmitQcDate': '2021-08-03', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventriculitis extending from EVD insertion until discharge', 'timeFrame': 'EVD insertion until discharge- estimated period of time is 2 weeks', 'description': 'Patient has organism(s) identified from (CSF) by a culture or (i.e.; PCR) (1) or (2) must be met: Patient has at least two of the following:\n\na) fever (\\>38.0°C) or headache, b) meningeal sign(s), c) cranial nerve sign(s)\n\nAnd at least one of the following:\n\nd) increased white cells, elevated protein, and decreased glucose in CSF , e) organism(s) seen on Gram stain of CSF., f) organism(s) identified from blood by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, g) diagnostic single antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism\n\n1. Patient has organism(s) identified from cerebrospinal fluid (CSF) by a culture or non-culture based microbiologic testing method (i.e.; PCR) which is performed for purposes of clinical diagnosis or treatment OR\n2. Patient has at least two of the following:, a) fever (\\>38.0°C) or headache ,b) meningeal sign(s), c) cranial nerve sign(s)'}], 'secondaryOutcomes': [{'measure': 'Class of infecting organism', 'timeFrame': 'EVD insertion until discharge- estimated period of time is 2 weeks', 'description': 'assess if the infections that occur in both treatment groups are caused by the same type of pathogen'}, {'measure': 'Time to infection', 'timeFrame': 'EVD insertion until discharge- estimated period of time is 2 weeks', 'description': 'Evaluate time to infection from time to EVD placement'}, {'measure': 'Incidence of nosocomial infections', 'timeFrame': 'EVD insertion until discharge- estimated period of time is 2 weeks', 'description': 'incidence of C. difficile or multidrug resistant nosocomial infections in participants especially those who are on a longer course of antibiotics'}, {'measure': 'overall morbidity which is morbidity from all causes', 'timeFrame': 'EVD insertion until discharge- estimated period of time is 2 weeks', 'description': 'includes: high grade fever (\\>101 degrees Fahrenheit), repositioning of EVD, post procedural hemorrhage, or new catheter placement due to new bleeding (at a different location than original), need for permanent CSF drainage, i.e. ventriculoperitoneal shunt'}, {'measure': 'Mortality', 'timeFrame': 'EVD insertion until discharge- estimated period of time is 3 weeks', 'description': 'mortality from all causes that will be recorded along with cause of death if patient dies during the period of insertion of EVD until one week after its removal'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Subarachnoid hemorrhage', 'Intracerebral Hemorrhage', 'Ventriculitis', 'Hydrocephalus'], 'conditions': ['Subarachnoid Hemorrhage', 'Intracerebral Hemorrhage', 'Ventriculitis, Cerebral', 'Hydrocephalus']}, 'descriptionModule': {'briefSummary': 'The length of prophylactic antibiotic use with antibiotic impregnated External Ventricular Drains (EVD)s is unknown. This study is a randomized clinical trial with two arms:\n\n1. twenty four hours of prophylactic antibiotic use or\n2. prophylactic antibiotic use for entire duration of EVD', 'detailedDescription': 'The principle objective of this study is to compare the incidence of ventriculostomy related infections (VRIs) in patients who receive twenty-four hours of antibiotics, beginning no more than sixty minutes prior to EVD placement, to the incidence of VRIs in patients who also receive a pre-procedural dose of antibiotics with continued dosing of antibiotics for the duration of the external ventricular drain (EVD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients over the age of 18 years and patients diagnosed with a subarachnoid hemorrhage, intracerebral hemorrhage or acute ischemic stroke who require an EVD for management of their underlying condition.\n* In certain cases (a small minority), an EVD must be replaced due to failure (i.e.; blood clot interrupting flow). In such cases, patients will be re-dosed with antibiotics prior to catheter exchange in typical fashion, and continue in their previously randomized treatment group.\n\nExclusion Criteria:\n\n* patients who underwent any intracranial procedure in the 30 days prior,\n* patients who were on antibiotics within the week prior to admission,\n* patients with leukopenia (\\<5000) at baseline,\n* patients with signs of meningitis, ventriculitis or any other infection at presentation,\n* patients who are pregnant or prisoners.\n* patients aged \\< 18 years old'}, 'identificationModule': {'nctId': 'NCT05001750', 'briefTitle': 'Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Are Long Term Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?', 'orgStudyIdInfo': {'id': '2021-12680'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'continuous antibiotic use until the EVD is removed', 'description': 'continuous antibiotic use until the EVD is removed. Nafcillin 1-2 grams every 6 hours (depending on weight) until the EVD is removed. If penicillin allergic Doxycycline 100mg every 12 hours until the EVD is removed.', 'interventionNames': ['Drug: long term prophylactic antibiotics (Nafcillin or Doxycycline)']}, {'type': 'NO_INTERVENTION', 'label': 'antibiotics for a total of twenty-four hours', 'description': 'antibiotics for a total of twenty-four hours Nafcillin 1-2 grams every 6 hours (depending on weight) for a total of 24 hours. If penicillin allergic Doxycycline 100mg every 12 hours for a total of 24 hours.'}], 'interventions': [{'name': 'long term prophylactic antibiotics (Nafcillin or Doxycycline)', 'type': 'DRUG', 'otherNames': ['24 hours antibiotics'], 'description': 'VRIs in patients who also receive a pre-procedural dose of antibiotics with continued dosing of antibiotics for the duration of the external ventricular drain IRB NUMBER: 2021-12680 IRB APPROVAL DATE: 06/14/2021 NOABX in EVD Study 3 (EVD).', 'armGroupLabels': ['continuous antibiotic use until the EVD is removed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10452', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erida Castro Rivas, MS', 'role': 'CONTACT', 'email': 'ecastroriv@montefiore.org', 'phone': '718-920-4965'}, {'name': 'Lavinia C Williams', 'role': 'CONTACT', 'email': 'ecastroriv@montefiore.org', 'phone': '7189204965'}, {'name': 'David Altschul, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'centralContacts': [{'name': 'David C Altschul, MD', 'role': 'CONTACT', 'email': 'daltschul@montefiore.org', 'phone': '7189204965'}, {'name': 'Erida C Rivas', 'role': 'CONTACT', 'email': 'ecastroriv@montefiore.org', 'phone': '7189204965'}], 'overallOfficials': [{'name': 'David C Altschul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}