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

COVID19 Clinical Trial

— RASCALS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04233268
• Other study ID #: 277039
• Status: Recruiting
• Start date: June 6, 2020
• Est. completion date: February 28, 2025

Study information

• Verified date: October 2021
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: Nazima Pathan, FRCPCH PhD
• Phone: 01225245151
• Email: np409[@]cam.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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 Survival not expected/active medical treatment expected to be withdrawn/palliative care only

Related Conditions & MeSH terms

• Communicable Diseases
• COVID19
• Infections
• Lower Respiratory Tract Infection
• Pneumonia, Ventilator-Associated
• Respiratory Tract Infections
• Ventilator Associated Pneumonia

Intervention

Diagnostic Test:
• Rapid Pathogen Detection
Rapid assays for pathogen detection on bronchoalveolar lavage fluid

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge	Cambs

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevalence of COVID19 in children admitted to PICU	Number of critically ill children requiring mechanical ventilation with COVID19 compared to those without	2 years
Other	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
Primary	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	Time to results	Time to reportable test results	3 years
Secondary	Negative cultures	Where routine culture is negative, what proportion of tests have a positive detection using the novel assay?	3 years
Secondary	Antibiotic therapy	Duration of therapy and number of antibiotic classes during paediatric intensive care unit admission	3 years