RASCALS: Rapid Assay for Sick Children With Acute Lung Infection Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lower Respiratory Tract Infection
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Performance of the novel pathogen detection assay
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
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.
Investigators
Dr Nazima Pathan
University Lecturer in Paediatric Intensive Care
Cambridge University Hospitals NHS Foundation Trust
Eligibility Criteria
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
- •Survival not expected/active medical treatment expected to be withdrawn/palliative care only
Outcomes
Primary Outcomes
Performance of the novel pathogen detection assay
Time Frame: 3 years
Performance of novel pathogen detection assays compared to standard microbiology, in regard to sensitivity, specificity and likelihood ratios
Secondary Outcomes
- Time to results(3 years)
- Negative cultures(3 years)
- Antibiotic therapy(3 years)