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.

Sepsis Clinical Trial

— PIC  

Official title:

Petechiae In Children (PIC) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378258
• Other study ID #: EAT/5313/16
• Secondary ID: 17/NI/0169
• Status: Completed
• Start date: November 9, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: December 2019
• Source: Belfast Health and Social Care Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1329
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

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

• Features of meningococcal sepsis/meningitis

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal
• Meningococcal Disease
• Meningococcal Infections
• Meningococcal Sepsis
• Sepsis
• Toxemia

Locations

Country	Name	City	State
United Kingdom	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland

Sponsors (5)

Lead Sponsor	Collaborator
Belfast Health and Social Care Trust	Pediatric Emergency Research in the UK and Ireland (PERUKI), Public Health Agency (Northern Ireland), Queen's University, Belfast, Royal College of Emergency Medicine (RCEM)

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

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. — View 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. — View 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. — View 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.

NICE. Meningitis (bacterial) and meningococcal septicaemia in under 16s: recognition, diagnosis and management | Guidance and guidelines | NICE. 2015. https://www.nice.org.uk/guidance/cg102. Accessed 10 Oct 2017.

Nielsen HE, Andersen EA, Andersen J, Böttiger 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. — View Citation

Ó 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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