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.

NCT03378258 | Completed DMC

• 2 other identifiers: EAT/5313/1617/NI/0169
• Study Type: observational
• Target: 1,329
• Locations: 1 country
• Sites: 1

Brief Summary

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. In particular the investigators are interested in researching how quick bedside tests can be used to do this.

Conditions

Meningitis, Meningococcal; Meningococcal Sepsis; Meningococcal Disease; Meningococcal Infections; Sepsis; Meningitis

Keywords

meningococcal; neisseria meningitidis; sepsis; meningitis; procalcitonin; PCT; LAMP; loop-mediated-isothermal AMPlification

Outcome Measures

Primary Outcomes (1)

• Confirmation of meningococcal infection

  Blood and Cerebrospinal fluid (CSF) culture or quantitative Polymerase Chain Reaction (PCR) will be used to confirm meningococcal infection

  72 hours from testing

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Fever (recorded or reported) 38 degrees Centigrade or higher and a non-blanching rash (at the time of presentation)
• Features of meningococcal sepsis/meningitis

You may not qualify if:

• Known haematological conditions such as haematological malignancy, idiopathic thrombocytopenic purpura and coagulopathy

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead
• Pediatric Emergency Research in the UK and Ireland (PERUKI): collaborator
• Royal College of Emergency Medicine: collaborator
• Queen's University, Belfast: collaborator
• Public Health Agency (Northern Ireland): collaborator

Study Sites (1)

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT126BE, United Kingdom

Location

Related Publications (13)

• 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.

  BACKGROUND

• 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: 27566800 BACKGROUND

• 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: 32207890 BACKGROUND

• 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: 25728843 BACKGROUND

• 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: 11087287 BACKGROUND

• 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: 9329416 BACKGROUND

• 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: 11466193 BACKGROUND

• 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: 26984401 BACKGROUND

• 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: 33186517 DERIVED

• 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: 33087092 DERIVED

• 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: 32586928 DERIVED

• 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: 31175126 DERIVED

• 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.

  PMID: 30060751 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma for testing of biomarkers

MeSH Terms

Conditions

Meningitis, Meningococcal; Meningococcal Infections; Sepsis; Meningitis

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MIchael D Shields

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 19, 2017
• Study Start: November 9, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: December 12, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data requests will be reviewed by an external independent review panel. Requesters will be required to sign a data access agreement.

Locations

GB (1)