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.
NCT ID: NCT03378258
Last Updated: 2019-12-12
Study Results
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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COMPLETED
1329 participants
OBSERVATIONAL
2017-11-09
2019-06-30
Brief Summary
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In particular the investigators are interested in researching how quick bedside tests can be used to do this.
Detailed Description
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The aim of the PIC study is to research how to better diagnose those serious infections earlier.
Data from the study will be used to test the effectiveness of current practice and to identify areas where current practice could be improved.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Features of meningococcal sepsis/meningitis
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Pediatric Emergency Research in the UK and Ireland (PERUKI)
OTHER
Royal College of Emergency Medicine
OTHER
Queen's University, Belfast
OTHER
Public Health Agency (Northern Ireland)
UNKNOWN
Belfast Health and Social Care Trust
OTHER
Responsible Party
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Principal Investigators
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MIchael D Shields
Role: PRINCIPAL_INVESTIGATOR
Queen's University, Belfast
Locations
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Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Countries
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References
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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.
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.
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/
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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17/NI/0169
Identifier Type: OTHER
Identifier Source: secondary_id
EAT/5313/16
Identifier Type: -
Identifier Source: org_study_id