An observational study in Meningitis, Meningococcal, Meningococcal Sepsis and Meningococcal Disease, sponsored by Belfast Health and Social Care Trust. Completed at 1 site in United Kingdom. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2019-12-12.
Sponsored by Belfast Health and Social Care Trust · Observational
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.
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.
125 studies on the registry are indexed under Meningitis, Meningococcal; 10 are open to participants now.
This study's enrollment of 1,329 is above the median of 180 across 11 observational studies indexed under Meningitis, Meningococcal.
Browse Meningitis, Meningococcal studies →Belfast Health and Social Care Trust is the lead sponsor of 45 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Confirmation of meningococcal infection
Blood and Cerebrospinal fluid (CSF) culture or quantitative Polymerase Chain Reaction (PCR) will be used to confirm meningococcal infection
Time frame: 72 hours from testing
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
Ran from Nov 2017 to primary completion in Jun 2019, 19 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Belfast Health and Social Care Trust