Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-01 @ 1:55 PM
Study NCT ID:
NCT04233268
Status:
UNKNOWN
Last Update Posted:
2021-10-20
First Post:
2020-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RASCALS: Rapid Assay for Sick Children With Acute Lung Infection Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Bronchoalveolar Lavage fluid, Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-12', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Prevalence of COVID19 in children admitted to PICU', 'timeFrame': '2 years', 'description': 'Number of critically ill children requiring mechanical ventilation with COVID19 compared to those without'}, {'measure': 'Prevalence of SARS-CoV-2 antigen in faecal samples following acute admission with COVID-19 related illness', 'timeFrame': '2 years', 'description': 'Faecal excretion of SARS-CoV-2'}], 'primaryOutcomes': [{'measure': 'Performance of the novel pathogen detection assay', 'timeFrame': '3 years', 'description': 'Performance of novel pathogen detection assays compared to standard microbiology, in regard to sensitivity, specificity and likelihood ratios'}], 'secondaryOutcomes': [{'measure': 'Time to results', 'timeFrame': '3 years', 'description': 'Time to reportable test results'}, {'measure': 'Negative cultures', 'timeFrame': '3 years', 'description': 'Where routine culture is negative, what proportion of tests have a positive detection using the novel assay?'}, {'measure': 'Antibiotic therapy', 'timeFrame': '3 years', 'description': 'Duration of therapy and number of antibiotic classes during paediatric intensive care unit admission'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lower Respiratory Tract Infection', 'Ventilator Associated Pneumonia', 'COVID19']}, 'referencesModule': {'references': [{'pmid': '37425493', 'type': 'DERIVED', 'citation': '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': '34845080', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nA rapid assay to detect the most likely cause of infection could improve the speed with which antibiotic therapy is rationalised or curtailed.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '0 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill children with suspected lower respiratory tract infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged \\>37 weeks corrected gestation and ≤16 years old\n2. Receiving mechanical ventilation\n3. Commencing or already receiving antibiotic treatment for lower respiratory tract infection\n\nExclusion Criteria:\n\n1\\. Survival not expected/active medical treatment expected to be withdrawn/palliative care only'}, 'identificationModule': {'nctId': 'NCT04233268', 'acronym': 'RASCALS', 'briefTitle': 'RASCALS: Rapid Assay for Sick Children With Acute Lung Infection Study', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'RASCALS: Rapid Assay for Sick Children With Acute Lung Infection Study', 'orgStudyIdInfo': {'id': '277039'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critically ill children', 'description': 'Children with severe infection requiring mechanical ventilation', 'interventionNames': ['Diagnostic Test: Rapid Pathogen Detection']}, {'label': 'Non critically ill cohort', 'description': 'Children with severe infection admitted to hospital but not requiring mechanical ventilation'}, {'label': 'Profiling of the respiratory microbiome', 'description': 'Mechanically ventilated children of any cause admitted to PICU', 'interventionNames': ['Diagnostic Test: Rapid Pathogen Detection']}], 'interventions': [{'name': 'Rapid Pathogen Detection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Rapid assays for pathogen detection on bronchoalveolar lavage fluid', 'armGroupLabels': ['Critically ill children', 'Profiling of the respiratory microbiome']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 9NS', 'city': 'Cambridge', 'state': 'Cambs', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Nazima Pathan, FRCPCH PhD', 'role': 'CONTACT'}], 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'centralContacts': [{'name': 'Nazima Pathan, FRCPCH PhD', 'role': 'CONTACT', 'email': 'np409@cam.ac.uk', 'phone': '01225245151'}], 'overallOfficials': [{'name': 'Nazima Pathan, FRCPCH PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cambridge University Hospitals NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University Lecturer in Paediatric Intensive Care', 'investigatorFullName': 'Dr Nazima Pathan', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}