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

NCT ID: NCT04233268

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-06

Study Completion Date

2025-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Lower Respiratory Tract Infection Ventilator Associated Pneumonia COVID19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Critically ill children

Children with severe infection requiring mechanical ventilation

Rapid Pathogen Detection

Intervention Type DIAGNOSTIC_TEST

Rapid assays for pathogen detection on bronchoalveolar lavage fluid

Non critically ill cohort

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

No interventions assigned to this group

Profiling of the respiratory microbiome

Mechanically ventilated children of any cause admitted to PICU

Rapid Pathogen Detection

Intervention Type DIAGNOSTIC_TEST

Rapid assays for pathogen detection on bronchoalveolar lavage fluid

Interventions

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Rapid Pathogen Detection

Rapid assays for pathogen detection on bronchoalveolar lavage fluid

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

0 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Dr Nazima Pathan

University Lecturer in Paediatric Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nazima Pathan, FRCPCH PhD

Role: PRINCIPAL_INVESTIGATOR

Cambridge University Hospitals NHS Foundation Trust

Locations

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Addenbrooke's Hospital

Cambridge, Cambs, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Nazima Pathan, FRCPCH PhD

Role: CONTACT

[email protected]
01225245151

Facility Contacts

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Nazima Pathan, FRCPCH PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37425493 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34845080 (View on PubMed)

Other Identifiers

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277039

Identifier Type: -

Identifier Source: org_study_id