Rapid Assay for Sick Children with Acute Lung infection Study (RASCALS): diagnostic cohort study protocol
Autor: | Theodore Gouliouris, M. Estée Török, John Alexander Clark, Stephen Baker, Shruti Agrawal, Andrew Conway Morris, Iain Kean, Josefin Bartholdson Scott, Zhenguang Zhang, Fahad A Khokhar, Martin D. Curran, David Inwald, Nazima Pathan, Vilas Navapurkar, Mailis Maes, Deborah White, Esther Daubney, Rachel Bousfield |
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Přispěvatelé: | Clark, John Alexander [0000-0001-6916-9195], Török, M Estée [0000-0001-9098-8590], Apollo - University of Cambridge Repository, Clark, John [0000-0001-6916-9195], Conway Morris, Andrew [0000-0002-3211-3216], Baker, Stephen [0000-0003-1308-5755], Pathan, Nazima [0000-0002-9447-4252] |
Rok vydání: | 2021 |
Předmět: |
medicine.medical_specialty
paediatric intensive & critical care Concordance Cohort Studies molecular diagnostics respiratory infections Informed consent Lower respiratory tract infection RNA Ribosomal 16S medicine Humans Prospective Studies Medical prescription Prospective cohort study Child Lung business.industry Paediatrics General Medicine Pneumonia medicine.disease Observational Studies as Topic Emergency medicine Medicine Observational study business Cohort study |
Zdroj: | BMJ Open BMJ Open, Vol 11, Iss 11 (2021) |
ISSN: | 2044-6055 |
Popis: | IntroductionLower respiratory tract infection (LRTI) is the most commonly treated infection in critically ill children. Pathogens are infrequently identified on routine respiratory culture, and this is a time-consuming process. A syndromic approach to rapid molecular testing that includes a wide range of bacterial and fungal targets has the potential to aid clinical decision making and reduce unnecessary broad spectrum antimicrobial prescribing. Here, we describe a single-centre prospective cohort study investigating the use of a 52-pathogen TaqMan array card (TAC) for LRTI in the paediatric intensive care unit (PICU).Methods and analysisCritically ill children with suspected LRTI will be enrolled to this 100 patient single-centre prospective observational study in a PICU in the East of England. Samples will be obtained via routine non-bronchoscopic bronchoalveolar lavage which will be sent for standard microbiology culture in addition to TAC. A blood draw will be obtained via any existing vascular access device. The primary outcomes of the study will be (1) concordance of TAC result with routine culture and 16S rRNA gene sequencing and (2) time of diagnostic result from TAC versus routine culture. Secondary outcomes will include impact of the test on total antimicrobial prescriptions, a description of the inflammatory profile of the lung and blood in response to pneumonia and a description of the clinical experience of medical and nursing staff using TAC.Ethics and disseminationThis study has been approved by the Yorkshire and the Humber-Bradford Leeds Research Ethics Committee (REC reference 20/YH/0089). Informed consent will be obtained from all participants. Results will be published in peer-reviewed publications and international conferences.Trial registration numberNCT04233268. |
Databáze: | OpenAIRE |
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