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. (PIC)

December 10, 2019 updated by: Belfast Health and Social Care Trust

Petechiae In Children (PIC) Study

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1329

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT126BE
        • Royal Belfast Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belfast Health and Social Care Trust

Collaborators

Queen's University, Belfast
Royal College of Emergency Medicine
Pediatric Emergency Research in the UK and Ireland (PERUKI)
Public Health Agency (Northern Ireland)

Investigators

  • Principal Investigator: MIchael D Shields, Queen's University, Belfast

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2017

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

November 27, 2017

First Submitted That Met QC Criteria

December 18, 2017

First Posted (Actual)

December 19, 2017

Study Record Updates

Last Update Posted (Actual)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAT/5313/16
  • 17/NI/0169 (Other Identifier: Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

Data will be available within 6 months of study completion

IPD Sharing Access Criteria

Data requests will be reviewed by an external independent review panel. Requesters will be required to sign a data access agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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