RASCALS: Rapid Assay for Sick Children With Acute Lung Infection Study (RASCALS)

Lower Respiratory Tract infections are a common cause of admission to the intensive care unit. Children routinely receive antibiotics until the tests confirm whether the infection is bacterial or viral. The exclusion of bacterial infection may take 48 hours or longer for culture tests on biological samples to be completed. In many cases, the results may be inconclusive or negative if the patient has already received antibiotics prior to the sample being taken.

A rapid assay to detect the most likely cause of infection could improve the speed with which antibiotic therapy is rationalised or curtailed.

This study aims to assess whether a new genetic testing kit which can identify the presence of bacteria and viruses within hours rather than days is a feasible tool in improving antibiotic prescribing and rationalisation of therapy in critically ill children with suspected lower respiratory tract infection.

Study Overview

• Status: Recruiting
• Conditions: Ventilator Associated Pneumonia; COVID19; Lower Respiratory Tract Infection
• Intervention / Treatment: Diagnostic test: Rapid Pathogen Detection

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Nazima Pathan, FRCPCH PhD; Phone Number: 01225245151; Email: np409@cam.ac.uk

Study Locations

• United Kingdom
  • Cambs
    • Cambridge, Cambs, United Kingdom, CB2 9NS
      • Recruiting
      • Addenbrooke's Hospital
      • Contact: Nazima Pathan, FRCPCH PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Critically ill children with suspected lower respiratory tract infection

Description

Inclusion Criteria:

1. Aged >37 weeks corrected gestation and ≤16 years old
2. Receiving mechanical ventilation
3. Commencing or already receiving antibiotic treatment for lower respiratory tract infection

Exclusion Criteria:

1. Survival not expected/active medical treatment expected to be withdrawn/palliative care only

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Critically ill children; Children with severe infection requiring mechanical ventilation	Diagnostic test: Rapid Pathogen Detection; Rapid assays for pathogen detection on bronchoalveolar lavage fluid
Non critically ill cohort; Children with severe infection admitted to hospital but not requiring mechanical ventilation
Profiling of the respiratory microbiome; Mechanically ventilated children of any cause admitted to PICU	Diagnostic test: Rapid Pathogen Detection; Rapid assays for pathogen detection on bronchoalveolar lavage fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the novel pathogen detection assay	Performance of novel pathogen detection assays compared to standard microbiology, in regard to sensitivity, specificity and likelihood ratios	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to results	Time to reportable test results	3 years
Negative cultures	Where routine culture is negative, what proportion of tests have a positive detection using the novel assay?	3 years
Antibiotic therapy	Duration of therapy and number of antibiotic classes during paediatric intensive care unit admission	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of COVID19 in children admitted to PICU	Number of critically ill children requiring mechanical ventilation with COVID19 compared to those without	2 years
Prevalence of SARS-CoV-2 antigen in faecal samples following acute admission with COVID-19 related illness	Faecal excretion of SARS-CoV-2	2 years

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Nazima Pathan, FRCPCH PhD, Cambridge University Hospitals NHS Foundation Trust

Publications and helpful links

General Publications

• Clark JA, Kean IRL, Curran MD, Khokhar F, White D, Daubney E, Conway Morris A, Navapurkar V, Bartholdson Scott J, Maes M, Bousfield R, Gouliouris T, Agrawal S, Inwald D, Zhang Z, Torok ME, Baker S, Pathan N. Rapid Assay for Sick Children with Acute Lung infection Study (RASCALS): diagnostic cohort study protocol. BMJ Open. 2021 Nov 29;11(11):e056197. doi: 10.1136/bmjopen-2021-056197.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2020
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2025

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Infections; Communicable Diseases; Respiratory Tract Infections; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: 277039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No