Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Nov 29;11(11):e056197.
doi: 10.1136/bmjopen-2021-056197.

Rapid Assay for Sick Children with Acute Lung infection Study (RASCALS): diagnostic cohort study protocol

John Alexander Clark  1   2 , Iain Robert Louis Kean  3 , Martin D Curran  4 , Fahad Khokhar  5 , Deborah White  2 , Esther Daubney  2 , Andrew Conway Morris  2 , Vilas Navapurkar  2 , Josefin Bartholdson Scott  5 , Mailis Maes  5 , Rachel Bousfield  2 , Theodore Gouliouris  6 , Shruti Agrawal  3   2 , David Inwald  2 , Zhenguang Zhang  3 , M Estée Török  6 , Stephen Baker  5 , Nazima Pathan  3   2
Affiliations

Rapid Assay for Sick Children with Acute Lung infection Study (RASCALS): diagnostic cohort study protocol

John Alexander Clark et al. BMJ Open. .

Abstract

Introduction: Lower 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 analysis: Critically 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 dissemination: This 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 number: NCT04233268.

Keywords: molecular diagnostics; paediatric intensive & critical care; respiratory infections.

PubMed Disclaimer

Conflict of interest statement

Competing interests: MDC is the inventor on a patent held by the Secretary of State for Health (UK government) EP2788503, which covers some of the genetic sequences used in this study. VN is a founder, director and shareholder in Cambridge Infection Diagnostics (CID) which is a commercial company aimed at developing molecular diagnostics in infection and antimicrobial and AMR stewardship. ACM, SB and ED are members of the Scientific Advisory Board of Cambridge Infection Diagnostics (CID). TG has received a research grant from Shionogi. All other authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Power calculation. Calculation generated with ClinCalc.
Figure 2
Figure 2
Workflow. LRTI, lower respiratory tract infection; qPCR, quantitative PCR; TAC, Taqman Array Card.
See this image and copyright information in PMC

References

    1. GBD 2016 Causes of Death Collaborators . Global, regional, and national age-sex specific mortality for 264 causes of death, 1980-2016: a systematic analysis for the global burden of disease study 2016. Lancet 2017;390:1151–210. 10.1016/S0140-6736(17)32152-9 - DOI - PMC - PubMed
    1. Paediatric Intensive Care Audit Network . Paediatric Intensive Care Audit Network Annual Report 2019; 2019.
    1. Kumar A, Roberts D, Wood KE, et al. . Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med 2006;34:1589–96. 10.1097/01.CCM.0000217961.75225.E9 - DOI - PubMed
    1. da Silva PSL, de Aguiar VE, de Carvalho WB, et al. . Value of clinical pulmonary infection score in critically ill children as a surrogate for diagnosis of ventilator-associated pneumonia. J Crit Care 2014;29:545–50. 10.1016/j.jcrc.2014.01.010 - DOI - PubMed
    1. Sachdev A, Chugh K, Sethi M, et al. . Clinical pulmonary infection score to diagnose ventilator-associated pneumonia in children. Indian Pediatr 2011;48:949–54. 10.1007/s13312-011-0154-2 - DOI - PubMed

Publication types

Substances

Associated data