Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-02-25 @ 6:59 PM
Study NCT ID:
NCT04190303
Status:
COMPLETED
Last Update Posted:
2025-03-03
First Post:
2019-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BIGlobal Intervention Study: Improving Diagnosis and Management of Suspected Brain Infections Globally
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001922', 'term': 'Brain Abscess'}], 'ancestors': [{'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000038', 'term': 'Abscess'}, {'id': 'D013492', 'term': 'Suppuration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2233}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2019-12-01', 'studyFirstSubmitQcDate': '2019-12-04', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbiological diagnosis', 'timeFrame': 'During hospital admission, or at 30 days if participant still in hospital', 'description': 'Proportion of patients achieving microbiological diagnosis'}, {'measure': 'Syndromic diagnosis', 'timeFrame': 'During hospital admission, or at 30 days if participant still in hospital', 'description': 'Proportion of patients achieving syndromic diagnosis'}], 'secondaryOutcomes': [{'measure': 'Proportion receiving, and time to lumbar puncture', 'timeFrame': 'During hospital admission, or at 30 days if participant still in hospital', 'description': 'Proportion of study participants receiving a lumbar puncture, and time to lumbar puncture'}, {'measure': 'Proportion having appropriate cerebrospinal fluid investigations', 'timeFrame': 'During hospital admission, or at 30 days if participant still in hospital', 'description': 'All of: cell count, total and differential; CSF protein concentration; CSF glucose concentration; paired serum/blood glucose concentration; microscopy and culture for bacteria'}, {'measure': 'Mortality', 'timeFrame': 'At 30 days', 'description': 'All-cause'}, {'measure': 'Length of stay in hospital', 'timeFrame': 'During hospital admission, or at 30 days if participant still in hospital', 'description': 'Duration of hospital admission'}, {'measure': 'Time to appropriate empirical therapy', 'timeFrame': 'During hospital admission, or at 30 days if participant still in hospital', 'description': 'Time to appropriate empirical anti-infective therapy'}, {'measure': 'Time to appropriate definitive therapy', 'timeFrame': 'During hospital admission, or at 30 days if participant still in hospital', 'description': 'Time to appropriate definitive anti-infective therapy'}, {'measure': 'Quality of life score', 'timeFrame': 'At hospital discharge, or at 30 days if participant still in hospital', 'description': 'Using EuroQol EQ-5D questionnaires scoring 5 domains at levels 1-3 each, and an overall health state from 0 to 100.'}, {'measure': 'Quality of life score', 'timeFrame': 'At 30 days after presentation to hospital', 'description': 'Using EuroQol EQ-5D questionnaires scoring 5 domains at levels 1-3 each, and an overall health state from 0 to 100.'}, {'measure': 'Liverpool Outcome Score', 'timeFrame': 'At hospital discharge, or at 30 days if participant still in hospital', 'description': 'Score measuring neurological function after brain infection, reporting a lowest score of 15 domains between 2 and 5, and a total score with range 33-75.'}, {'measure': 'Liverpool Outcome Score', 'timeFrame': 'At 30 days after presentation to hospital', 'description': 'Score measuring neurological function after brain infection, reporting a lowest score of 15 domains between 2 and 5, and a total score with range 33-75.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meningitis', 'Encephalitis', 'Abscess Brain']}, 'referencesModule': {'references': [{'pmid': '40081400', 'type': 'DERIVED', 'citation': 'Singh B, Lipunga GD, Thangavelu P, Dhar S, Ferreira Cronemberger L, Abhilash KPP, Abraham AM, de Brito CAA, Brito Ferreira ML, Chandrashekar N, Duarte R, Fajardo Modol A, Ghale BC, Kang G, Gowda VK, Kuriakose K, Lant S, Mallewa M, Mbale E, Moore SC, Mwangalika G, Kamath PBT, Navvuga P, Nyondo-Mipando AL, Phiri TJ, Pimentel Lopes de Melo C, Pradeep BS, Rawlinson R, Sheha I, Thomas PT, Newton CR, de Sequeira PC, Sejvar JJ, Dua T, Turtle L, Verghese VP, Arraes LWMS, Desmond N, Easton A, Jones JA, Lilford RJ, Netravathi M, McGill F, Michael BD, Mwapasa V, Griffiths MJ, Parry CM, Ravi V, Burnside G; Brain Infections Global Intervention Study Group; Cornick J, Franca RFO, Desai AS, Rupali P, Solomon T. A multifaceted intervention to improve diagnosis and early management of hospitalised patients with suspected acute brain infections in Brazil, India, and Malawi: an international multicentre intervention study. Lancet. 2025 Mar 22;405(10483):991-1003. doi: 10.1016/S0140-6736(25)00263-6. Epub 2025 Mar 10.'}]}, 'descriptionModule': {'briefSummary': "Background: Patients with suspected brain infections pose major challenges to low and middle income countries, including their disproportionately high burden, diverse causes with inadequate surveillance, requirement for invasive and expensive tests, and the difficulty of management without a clear diagnosis. This is all compounded by resource and system constraints. Few studies have attempted to improve the care of these people in resource-limited settings.\n\nAim: This study sets out to improve the diagnosis and early management of people with suspected acute (\\<28 days of symptoms) brain infections in low and middle income countries, using a coordinated thematic approach.\n\nOutcomes: The primary outcome will be proportion of people with suspected acute brain infection receiving a diagnosis. Secondary outcomes will include mortality, length of stay in hospital, quality of life, degree of disability, and proportion having a lumbar puncture test.\n\nParticipants: Children and adults with features consistent with an acute brain infection, including meningitis and encephalitis, will be recruited at a variety of hospitals in Brazil, India and Malawi.\n\nStudy procedures: An assessment of current practice and capabilities at each hospital, including patient and sample journey observations and interviews with healthcare staff, will identify barriers to optimal care. Using this, a sustainable pragmatic multi-component intervention will be produced, with components modifiable to each hospital's needs. Outcomes will be reassessed post-intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Weeks', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to a study hospital with symptoms and/or signs suggestive of an acute brain infection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults, infants and children presenting to a study hospital with symptoms and/or signs suggestive of acute brain infection, which could be suspected encephalitis, suspected meningitis, or alternative features raising suspicion of brain infection.\n2. Symptom duration of less than 4 weeks.\n\nExclusion Criteria:\n\n1. Neonates, i.e. children under the age of 28 days.\n2. People with pre-existing indwelling ventricular devices (e.g. extra-ventricular drains, ventriculo-peritoneal shunts) or other implants in contact with the meninges or brain (e.g. deep brain stimulators).\n3. People without an indwelling device, having undergone neurosurgical procedures within the preceding 12 months.'}, 'identificationModule': {'nctId': 'NCT04190303', 'briefTitle': 'BIGlobal Intervention Study: Improving Diagnosis and Management of Suspected Brain Infections Globally', 'organization': {'class': 'OTHER', 'fullName': 'University of Liverpool'}, 'officialTitle': 'NIHR Global Health Research Group on Brain Infections Study: Establishing a Standard Care Package to Improve Diagnosis and Early Hospital Management of Patients With Suspected Acute Brain Infections in Low and Middle Income Countries', 'orgStudyIdInfo': {'id': 'UoL001430 - 4069'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Baseline (pre-intervention)', 'description': 'Current routine care'}, {'label': 'Post-intervention', 'description': 'Care following development and delivery of the system-level intervention', 'interventionNames': ['Other: Pragmatic, multi-component package']}], 'interventions': [{'name': 'Pragmatic, multi-component package', 'type': 'OTHER', 'description': 'This system-level intervention will be tailored to the needs and capacity of each hospital site, co-developed with policymakers and hospital staff', 'armGroupLabels': ['Post-intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Recife', 'country': 'Brazil', 'facility': 'FioCruz', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'city': 'Bangalore', 'country': 'India', 'facility': 'National Institute of Mental Health and Neurosciences', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Vellore', 'country': 'India', 'facility': 'Christian Medical College', 'geoPoint': {'lat': 12.9184, 'lon': 79.13255}}, {'city': 'Blantyre', 'country': 'Malawi', 'facility': 'Malawi Liverpool Wellcome Trust', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}], 'overallOfficials': [{'name': 'Tom Solomon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Infection & Global Health, University of Liverpool'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liverpool', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}, {'name': 'Christian Medical College, Vellore, India', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health and Neuro Sciences, India', 'class': 'OTHER'}, {'name': 'Oswaldo Cruz Foundation', 'class': 'OTHER'}, {'name': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme', 'class': 'OTHER'}, {'name': 'Kamuzu University of Health Sciences', 'class': 'OTHER'}, {'name': 'University of Warwick', 'class': 'OTHER'}, {'name': 'Liverpool School of Tropical Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Tom Solomon', 'investigatorAffiliation': 'University of Liverpool'}}}}