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

Study Overview
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Brief Summary
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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.

Official Title
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RASCALS: Rapid Assay for Sick Children With Acute Lung Infection Study

Conditions
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COVID19, Lower Respiratory Tract Infection, Ventilator Associated Pneumonia

Intervention / Treatment
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* Diagnostic Test: Rapid Pathogen Detection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged >37 weeks corrected gestation and ≤16 years old Receiving mechanical ventilation 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 Survival not expected/active medical treatment expected to be withdrawn/palliative care only

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically ill children<br>Children with severe infection requiring mechanical ventilation | Diagnostic Test: Rapid Pathogen Detection<br>* Rapid assays for pathogen detection on bronchoalveolar lavage fluid<br>|
| Non critically ill cohort<br>Children with severe infection admitted to hospital but not requiring mechanical ventilation | |
| Profiling of the respiratory microbiome<br>Mechanically ventilated children of any cause admitted to PICU | Diagnostic Test: Rapid Pathogen Detection<br>* Rapid assays for pathogen detection on bronchoalveolar lavage fluid<br>|

What is the study measuring?
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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 |