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

NHS Foundation Trust

Status: Enrolling

Conditions: Ventilator Associated Pneumonia; Lower Respiratory Tract Infection; COVID19

Treatments: Diagnostic Test: Rapid Pathogen Detection

Study type: Observational

Funder types: Other

Identifiers

NCT04233268

277039

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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 Survival not expected/active medical treatment expected to be withdrawn/palliative care only

Trial design

250 participants in 3 patient groups

Critically ill children

Description:

Children with severe infection requiring mechanical ventilation

Treatment:

Diagnostic Test: Rapid Pathogen Detection

Non critically ill cohort

Description:

Children with severe infection admitted to hospital but not requiring mechanical ventilation

Profiling of the respiratory microbiome

Description:

Mechanically ventilated children of any cause admitted to PICU

Treatment:

Diagnostic Test: Rapid Pathogen Detection