Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-22 @ 12:23 PM
Study NCT ID:
NCT03378258
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2017-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Petechiae In Children (PIC) Study: Defining A Clinical Decision Rule for The Management Of Fever and Non-Blanching Rashes In Children Including The Role Of Point Of Care Testing For Procalcitonin & Neisseria Meningitidis DNA.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008585', 'term': 'Meningitis, Meningococcal'}, {'id': 'D008589', 'term': 'Meningococcal Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D008581', 'term': 'Meningitis'}], 'ancestors': [{'id': 'D016920', 'term': 'Meningitis, Bacterial'}, {'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'plasma for testing of biomarkers'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1329}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-10', 'studyFirstSubmitDate': '2017-11-27', 'studyFirstSubmitQcDate': '2017-12-18', 'lastUpdatePostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmation of meningococcal infection', 'timeFrame': '72 hours from testing', 'description': 'Blood and Cerebrospinal fluid (CSF) culture or quantitative Polymerase Chain Reaction (PCR) will be used to confirm meningococcal infection'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['meningococcal', 'neisseria meningitidis', 'sepsis', 'meningitis', 'procalcitonin', 'PCT', 'LAMP', 'loop-mediated-isothermal AMPlification'], 'conditions': ['Meningitis, Meningococcal', 'Meningococcal Sepsis', 'Meningococcal Disease', 'Meningococcal Infections', 'Sepsis', 'Meningitis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Meningitis Research Foundation. Meningococcal Meningitis and Septicaemia. 2016. https://www.meningitis.org/getmedia/cf777153-9427-4464-89e2-fb58199174b6/gp_booklet-UK-sept-16. Accessed 10 Oct 2017.'}, {'pmid': '27566800', 'type': 'BACKGROUND', 'citation': 'O Maoldomhnaigh C, Drew RJ, Gavin P, Cafferkey M, Butler KM. Invasive meningococcal disease in children in Ireland, 2001-2011. Arch Dis Child. 2016 Dec;101(12):1125-1129. doi: 10.1136/archdischild-2015-310215. Epub 2016 Aug 26.'}, {'pmid': '32207890', 'type': 'BACKGROUND', 'citation': 'Meningitis (bacterial) and meningococcal septicaemia in under 16s: recognition, diagnosis and management. London: National Institute for Health and Care Excellence (NICE); 2015 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK555182/'}, {'pmid': '25728843', 'type': 'BACKGROUND', 'citation': 'Bourke TW, McKenna JP, Coyle PV, Shields MD, Fairley DJ. Diagnostic accuracy of loop-mediated isothermal amplification as a near-patient test for meningococcal disease in children: an observational cohort study. Lancet Infect Dis. 2015 May;15(5):552-8. doi: 10.1016/S1473-3099(15)70038-1. Epub 2015 Feb 27.'}, {'pmid': '11087287', 'type': 'BACKGROUND', 'citation': 'Brogan PA, Raffles A. The management of fever and petechiae: making sense of rash decisions. Arch Dis Child. 2000 Dec;83(6):506-7. doi: 10.1136/adc.83.6.506.'}, {'pmid': '9329416', 'type': 'BACKGROUND', 'citation': 'Mandl KD, Stack AM, Fleisher GR. Incidence of bacteremia in infants and children with fever and petechiae. J Pediatr. 1997 Sep;131(3):398-404. doi: 10.1016/s0022-3476(97)80065-0.'}, {'pmid': '11466193', 'type': 'BACKGROUND', 'citation': 'Nielsen HE, Andersen EA, Andersen J, Bottiger B, Christiansen KM, Daugbjerg P, Larsen SO, Lind I, Nir M, Olofsson K. Diagnostic assessment of haemorrhagic rash and fever. Arch Dis Child. 2001 Aug;85(2):160-5. doi: 10.1136/adc.85.2.160.'}, {'pmid': '26984401', 'type': 'BACKGROUND', 'citation': 'Riordan FA, Jones L, Clark J; Non-Blanching Rash Audit Group. Validation of two algorithms for managing children with a non-blanching rash. Arch Dis Child. 2016 Aug;101(8):709-13. doi: 10.1136/archdischild-2015-309451. Epub 2016 Mar 16.'}, {'pmid': '33186517', 'type': 'DERIVED', 'citation': 'Waterfield T, Maney JA, Fairley D, Lyttle MD, McKenna JP, Roland D, Corr M, McFetridge L, Mitchell H, Woolfall K, Lynn F, Patenall B, Shields MD; Paediatric Emergency Research in the UK and Ireland (PERUKI) Group. Validating clinical practice guidelines for the management of children with non-blanching rashes in the UK (PiC): a prospective, multicentre cohort study. Lancet Infect Dis. 2021 Apr;21(4):569-577. doi: 10.1016/S1473-3099(20)30474-6. Epub 2020 Nov 10.'}, {'pmid': '33087092', 'type': 'DERIVED', 'citation': 'Waterfield T, Maney JA, Lyttle MD, McKenna JP, Roland D, Corr M, Patenall B, Shields MD, Woolfall K, Fairley D; Paediatric Emergency Research in the UK and Ireland (PERUKI). Diagnostic test accuracy of point-of-care procalcitonin to diagnose serious bacterial infections in children. BMC Pediatr. 2020 Oct 21;20(1):487. doi: 10.1186/s12887-020-02385-2.'}, {'pmid': '32586928', 'type': 'DERIVED', 'citation': 'Waterfield T, Lyttle MD, McKenna J, Maney JA, Roland D, Corr M, Woolfall K, Patenall B, Shields M, Fairley D; Paediatric Emergency Research in the UK and Ireland (PERUKI). Loop-mediated isothermal amplification for the early diagnosis of invasive meningococcal disease in children. Arch Dis Child. 2020 Dec;105(12):1151-1156. doi: 10.1136/archdischild-2020-319139. Epub 2020 Jun 25.'}, {'pmid': '31175126', 'type': 'DERIVED', 'citation': "Waterfield T, Lyttle MD, Shields M, Fairley D, Roland D, McKenna J, Woolfall K; Paediatric Emergency Research in the UK and Ireland (PERUKI). Parents' and clinicians' views on conducting paediatric diagnostic test accuracy studies without prior informed consent: qualitative insight from the Petechiae in Children study (PiC). Arch Dis Child. 2019 Oct;104(10):979-983. doi: 10.1136/archdischild-2019-317117. Epub 2019 Jun 7."}, {'pmid': '30060751', 'type': 'DERIVED', 'citation': 'Waterfield T, Lyttle MD, Fairley D, Mckenna J, Woolfall K, Lynn F, Maney JA, Roland D, Weir A, Shields MD; Paediatric Emergency Research in the UK and Ireland (PERUKI). The "Petechiae in children" (PiC) study: evaluating potential clinical decision rules for the management of feverish children with non-blanching rashes, including the role of point of care testing for Procalcitonin & Neisseria meningitidis DNA - a study protocol. BMC Pediatr. 2018 Jul 30;18(1):246. doi: 10.1186/s12887-018-1220-x.'}]}, 'descriptionModule': {'briefSummary': 'A fever and a non-blanching rash is a relatively common reason for a child to attend an emergency department. A fever and a non-blanching rash can be an early sign of a life-threatening infection known as meningococcal disease. The aim of the PIC study is to determine how best to diagnose early meningococcal disease in children.\n\nIn particular the investigators are interested in researching how quick bedside tests can be used to do this.', 'detailedDescription': 'A fever an a non-blanching rash is a relatively common presentation the the emergency department. A minority of children with a fever and a non-blanching rash with have a life-threatening infection. Currently it is very difficult to determine those children that require urgent treatment from those that have a simple viral illness.\n\nThe aim of the PIC study is to research how to better diagnose those serious infections earlier.\n\nData from the study will be used to test the effectiveness of current practice and to identify areas where current practice could be improved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All Children \\<18 years of age (male and female) attending with a fever (recorded or reported) 38C and a non-blanching rash (at the time of presentation) or features of meningococcal sepsis/meningitis will be eligible for recruitment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fever (recorded or reported) 38 degrees Centigrade or higher and a non-blanching rash (at the time of presentation)\n* Features of meningococcal sepsis/meningitis\n\nExclusion Criteria:\n\n* Known haematological conditions such as haematological malignancy, idiopathic thrombocytopenic purpura and coagulopathy'}, 'identificationModule': {'nctId': 'NCT03378258', 'acronym': 'PIC', 'briefTitle': 'Petechiae In Children (PIC) Study: Defining A Clinical Decision Rule for The Management Of Fever and Non-Blanching Rashes In Children Including The Role Of Point Of Care Testing For Procalcitonin & Neisseria Meningitidis DNA.', 'organization': {'class': 'OTHER', 'fullName': 'Belfast Health and Social Care Trust'}, 'officialTitle': 'Petechiae In Children (PIC) Study', 'orgStudyIdInfo': {'id': 'EAT/5313/16'}, 'secondaryIdInfos': [{'id': '17/NI/0169', 'type': 'OTHER', 'domain': 'Research Ethics Committee'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT126BE', 'city': 'Belfast', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Royal Belfast Hospital for Sick Children', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'overallOfficials': [{'name': 'MIchael D Shields', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University, Belfast"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be available within 6 months of study completion', 'ipdSharing': 'YES', 'accessCriteria': 'Data requests will be reviewed by an external independent review panel. Requesters will be required to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Belfast Health and Social Care Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pediatric Emergency Research in the UK and Ireland (PERUKI)', 'class': 'OTHER'}, {'name': 'Royal College of Emergency Medicine', 'class': 'OTHER'}, {'name': "Queen's University, Belfast", 'class': 'OTHER'}, {'name': 'Public Health Agency (Northern Ireland)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}