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

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ClinicalTrials.gov Identifier: NCT04233268
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Nazima Pathan, Cambridge University Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment
Lower Respiratory Tract Infection Ventilator Associated Pneumonia COVID19 Diagnostic Test: Rapid Pathogen Detection

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: RASCALS: Rapid Assay for Sick Children With Acute Lung Infection Study
Actual Study Start Date : April 6, 2020
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Critically ill children
Children with severe infection requiring mechanical ventilation
Diagnostic Test: Rapid Pathogen Detection
Rapid assays for pathogen detection on bronchoalveolar lavage fluid

Non critically ill cohort
Children with suspected COVID19 admitted to hospital but not requiring mechanical ventilation
Diagnostic Test: Rapid Pathogen Detection
Rapid assays for pathogen detection on bronchoalveolar lavage fluid

Maternal and neonatal cohort
Babies born where mother has a recent diagnosis of COVID19
Diagnostic Test: Rapid Pathogen Detection
Rapid assays for pathogen detection on bronchoalveolar lavage fluid




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Time to results [ Time Frame: 3 years ]
    Time to reportable test results

  2. Negative cultures [ Time Frame: 3 years ]
    Where routine culture is negative, what proportion of tests have a positive detection using the novel assay?

  3. Antibiotic therapy [ Time Frame: 3 years ]
    Duration of therapy and number of antibiotic classes during paediatric intensive care unit admission

  4. Prevalence of COVID19 in children admitted to PICU [ Time Frame: 2 years ]
    Number of critically ill children requiring mechanical ventilation with COVID19 compared to those without


Biospecimen Retention:   Samples Without DNA
Bronchoalveolar Lavage fluid, Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critically ill children with suspected lower respiratory tract infection
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04233268


Contacts
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Contact: Nazima Pathan, FRCPCH PhD 01225245151 np409@cam.ac.uk

Locations
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United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, Cambs, United Kingdom, CB2 9NS
Contact: Nazima Pathan, FRCPCH PhD         
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Nazima Pathan, FRCPCH PhD Cambridge University Hospitals NHS Foundation Trust
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Responsible Party: Dr Nazima Pathan, University Lecturer in Paediatric Intensive Care, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04233268    
Other Study ID Numbers: 277039
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Cross Infection