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 |
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Recruitment Status :
Completed
First Posted : December 19, 2017
Last Update Posted : December 12, 2019
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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 |
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| Meningitis, Meningococcal Meningococcal Sepsis Meningococcal Disease Meningococcal Infections Sepsis Meningitis |
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 |
| Actual Enrollment : | 1329 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Petechiae In Children (PIC) Study |
| Actual Study Start Date : | November 9, 2017 |
| Actual Primary Completion Date : | June 30, 2019 |
| Actual Study Completion Date : | June 30, 2019 |
- 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
Biospecimen Retention: Samples Without DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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
| United Kingdom | |
| Royal Belfast Hospital for Sick Children | |
| Belfast, Northern Ireland, United Kingdom, BT126BE | |
| Principal Investigator: | MIchael D Shields | Queen's University, Belfast |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Belfast Health and Social Care Trust |
| ClinicalTrials.gov Identifier: | NCT03378258 |
| 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: | December 12, 2019 |
| Last Verified: | December 2019 |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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meningococcal neisseria meningitidis sepsis meningitis |
procalcitonin PCT LAMP loop-mediated-isothermal AMPlification |
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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 |