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Completed

NCT Number: NCT03378258

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.

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.

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Key information

Conditions

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

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT126BE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Belfast Health and Social Care Trust

Other

Collaborators

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

Registry information

Official study title

Petechiae In Children (PIC) Study

Acronym: PIC

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2017
Registry last updated
Dec 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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