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

Recruiting

• Conditions: Ventilator Associated Pneumonia; COVID19; Lower Respiratory Tract Infection
• Interventions: Diagnostic Test: Rapid Pathogen Detection

• Registration Number: NCT04233268
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Study Start: 2020-06-06
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-12
• Last Update Posted: 2021-10-20
• Primary Completion: 2023-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 Survival not expected/active medical treatment expected to be withdrawn/palliative care only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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Profiling of the respiratory microbiome	Rapid Pathogen Detection	Mechanically ventilated children of any cause admitted to PICU
Critically ill children	Rapid Pathogen Detection	Children with severe infection requiring mechanical ventilation

Primary Outcome Measures

Name	Time	Method
Performance of the novel pathogen detection assay	3 years	Performance of novel pathogen detection assays compared to standard microbiology, in regard to sensitivity, specificity and likelihood ratios

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Addenbrooke's Hospital; 🇬🇧 Cambridge, Cambs, United Kingdom