Skip to main content
Clinical Trials/NCT04233268
NCT04233268
Recruiting
Not Applicable

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

Cambridge University Hospitals NHS Foundation Trust1 site in 1 country250 target enrollmentJune 6, 2020

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.

Registry
clinicaltrials.gov
Start Date
June 6, 2020
End Date
February 28, 2025
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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  • Survival not expected/active medical treatment expected to be withdrawn/palliative care only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

Study Sites (1)

Loading locations...

Similar Trials