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.

Completed

• Conditions: Meningococcal Infections; Meningococcal Sepsis; Meningococcal Disease; Meningitis, Meningococcal; Sepsis; Meningitis

• Registration Number: NCT03378258
• Lead Sponsor: Belfast Health and Social Care Trust

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.

Detailed 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.

Study Timeline

• Study Start: 2017-11-09
• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-19
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1329

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confirmation of meningococcal infection	72 hours from testing	Blood and Cerebrospinal fluid (CSF) culture or quantitative Polymerase Chain Reaction (PCR) will be used to confirm meningococcal infection

Trial Locations

Locations (1)

Royal Belfast Hospital for Sick Children; 🇬🇧 Belfast, Northern Ireland, United Kingdom