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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.

Petechiae In Children (PIC) Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03378258
Acronym
PIC
Enrollment
1329
Registered
2017-12-19
Start date
2017-11-09
Completion date
2019-06-30
Last updated
2019-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Confirmation of meningococcal infection72 hours from testingBlood and Cerebrospinal fluid (CSF) culture or quantitative Polymerase Chain Reaction (PCR) will be used to confirm meningococcal infection

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026