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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. (PIC)

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ClinicalTrials.gov Identifier: NCT03378258
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : September 28, 2018
Sponsor:
Collaborators:
Pediatric Emergency Research in the UK and Ireland (PERUKI)
Royal College of Emergency Medicine (RCEM)
Queen's University, Belfast
Public Health Agency (Northern Ireland)
Information provided by (Responsible Party):
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.


Condition or disease
Meningitis, Meningococcal Meningococcal Sepsis Meningococcal Disease Meningococcal Infections Sepsis Meningitis

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.


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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Petechiae In Children (PIC) Study
Actual Study Start Date : November 9, 2017
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020





Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378258


Contacts
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Contact: Thomas Waterfield 02890633755 twaterfield01@qub.ac.uk
Contact: Michael D Shields 02890633755 m.shields@qub.ac.uk

Locations
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United Kingdom
Royal Belfast Hospital for Sick Children Recruiting
Belfast, Northern Ireland, United Kingdom, BT126BE
Contact: Thomas Waterfield    02890633755    twaterfield01@qub.ac.uk   
Contact: Michael Shields    02890633755    m.shields@qub.ac.uk   
Sponsors and Collaborators
Belfast Health and Social Care Trust
Pediatric Emergency Research in the UK and Ireland (PERUKI)
Royal College of Emergency Medicine (RCEM)
Queen's University, Belfast
Public Health Agency (Northern Ireland)
Investigators
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Principal Investigator: MIchael D Shields Queen's University, Belfast

Publications:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT03378258     History of Changes
Other Study ID Numbers: EAT/5313/16
17/NI/0169 ( Other Identifier: Research Ethics Committee )
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be available within 6 months of study completion
Access Criteria: Data requests will be reviewed by an external independent review panel. Requesters will be required to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Belfast Health and Social Care Trust:
meningococcal
neisseria meningitidis
sepsis
meningitis
procalcitonin
PCT
LAMP
loop-mediated-isothermal AMPlification
Additional relevant MeSH terms:
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Sepsis
Toxemia
Meningococcal Infections
Meningitis, Meningococcal
Meningitis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Central Nervous System Infections