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

NCT04233268 | Unknown DMC

• 1 other identifier: 277039
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Respiratory Tract Infection; Ventilator Associated Pneumonia; COVID19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to results

  3 years

• Negative cultures

  3 years

• Antibiotic therapy

  3 years

Other Outcomes (2)

• Prevalence of COVID19 in children admitted to PICU

  2 years

• Prevalence of SARS-CoV-2 antigen in faecal samples following acute admission with COVID-19 related illness

  2 years

Study Arms (3)

Critically ill children

Children with severe infection requiring mechanical ventilation

Diagnostic Test: Rapid Pathogen Detection

Non critically ill cohort

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

Profiling of the respiratory microbiome

Mechanically ventilated children of any cause admitted to PICU

Diagnostic Test: Rapid Pathogen Detection

Interventions

Rapid Pathogen Detection DIAGNOSTIC_TEST

Rapid assays for pathogen detection on bronchoalveolar lavage fluid

Critically ill children; Profiling of the respiratory microbiome

Eligibility Criteria

• Age: 0 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Critically ill children with suspected lower respiratory tract infection

You may qualify if:

• Aged \>37 weeks corrected gestation and ≤16 years old
• Receiving mechanical ventilation
• Commencing or already receiving antibiotic treatment for lower respiratory tract infection

You may not qualify if:

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 Survival not expected/active medical treatment expected to be withdrawn/palliative care only

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Addenbrooke's Hospital

Cambridge, Cambs, CB2 9NS, United Kingdom

RECRUITING

Related Publications (2)

• Clark JA, Conway Morris A, Kanaris C, Inwald D, Butt W, Osowicki J, Schlapbach LJ, Curran MD, White D, Daubney E, Agrawal S, Navapurkar V, Torok ME, Baker S, Pathan N. A qualitative investigation of paediatric intensive care staff attitudes towards the diagnosis of lower respiratory tract infection in the molecular diagnostics era. Intensive Care Med Paediatr Neonatal. 2023;1(1):10. doi: 10.1007/s44253-023-00008-z. Epub 2023 Jul 7.

  PMID: 37425493 DERIVED

• Clark JA, Kean IRL, Curran MD, Khokhar F, White D, Daubney E, Conway Morris A, Navapurkar V, Bartholdson Scott J, Maes M, Bousfield R, Gouliouris T, Agrawal S, Inwald D, Zhang Z, Torok ME, Baker S, Pathan N. Rapid Assay for Sick Children with Acute Lung infection Study (RASCALS): diagnostic cohort study protocol. BMJ Open. 2021 Nov 29;11(11):e056197. doi: 10.1136/bmjopen-2021-056197.

  PMID: 34845080 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bronchoalveolar Lavage fluid, Blood

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; COVID-19

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Nazima Pathan, FRCPCH PhD

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nazima Pathan, FRCPCH PhD

CONTACT

01225245151; np409@cam.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Lecturer in Paediatric Intensive Care

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: June 6, 2020
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2025
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)