Personalised Risk Assessment in Febrile Illness to Optimise Real-life Management Across the European Union (PERFORM) (PERFORM)
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|ClinicalTrials.gov Identifier: NCT03502993|
Recruitment Status : Recruiting
First Posted : April 19, 2018
Last Update Posted : May 27, 2019
Childhood fever is a prevalent problem. Most febrile children who visit hospital improve without treatment, but a minority require treatment, and a few will have severe disease. The investigators want to improve the diagnosis and management of febrile children by developing tests to distinguish between bacterial and viral disease so that antibiotic treatment can be initiated promptly and only when required. Judicious and prudent use of antibiotics will reduce the likelihood of developing resistant organisms and save treatment costs.
There are two parts to recruitment in this study; the first is to assess the management and outcome of febrile children who seek medical treatment in hospital (MOFICHE study). The data will be used to model management strategies for febrile children and enable a cost-effectiveness analysis.
Secondly the investigators will prospectively recruit acutely febrile children presenting to hospital, collecting research samples for validation of biomarkers, in combination with clinical phenotypic markers and host genetic markers (BIVA-studies).
Any febrile child newborn to under 18 presenting to hospital will be eligible for recruitment. The study will last 5 years.
|Condition or disease||Intervention/treatment|
|Fever Infection Inflammation||Diagnostic Test: Validation of biomarker Other: Antibiotic prescription Other: re-attendance at ED Other: Hospitalisation|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||54000 participants|
|Official Title:||Personalised Risk Assessment in Febrile Illness to Optimise Real-life Management Across the European Union (PERFORM)|
|Actual Study Start Date :||September 2016|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2022|
This is an observational study assessing the management and outcome of children presenting to Emergency Departments (ED) with fever across Europe. This study will use large departmental datasets to collect information on at least 50,000 febrile episodes . This study will use large-scale, pseudo-anonymized departmental data, and will not involve consented patient recruitment; nor will it use patient samples. Data included in MOFICHE will be based on that collected as part of routine clinical care. Antibiotic prescription, hospitalisation and number/type of investigations, re-attendance at ED within 5 days of the first hospital presentation will be recorded.
Other: Antibiotic prescription
Other: re-attendance at ED
A minimum of 3,000 children will be recruited to the BIVA-ED study, in order to capture sufficient children with confirmed bacterial infection. Additional children with less common febrile illnesses will also be recruited: 500 critically ill (BIVA-PIC); 200 at high-risk of bacterial illness through primary or secondary immunodeficiency (BIVA-HR); 150 with an inflammatory diagnosis, whose initial presentation is difficult to discriminate from bacterial infection (BIVA-INF). Samples collected from recruits in the BIVA studies will be used for the validation of biomarkers (clinical, proteomic and transcriptomic biomarkers) for diagnosis of febrile illness, including markers of bacterial and viral infection (confirmed by culture and/or molecular microbiology) and inflammatory conditions.
Diagnostic Test: Validation of biomarker
- MOFICHE study standardised dataset will be collected [ Time Frame: throughout the study over one year ]Duration of antimicrobial treatment
- BIVA studies assessment of the ability of biomarker tests [ Time Frame: throughout the study over 3 years ]Assessment of the ability of biomarker tests to distinguish between bacterial and viral disease in febrile children
- MOFICHE study accessed the records [ Time Frame: throughout the study one year ]Number of prescriptions of broad spectrum antibiotics versus the number of prescription of narrow spectrum antibiotics (dose in 24 hours)
- BIVA study assessment of the ability of biomarker tests to predict disease severity [ Time Frame: throughout the study 3 years ]Assessment of the ability of biomarker tests to predict disease severity
Biospecimen Retention: Samples With DNA
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): NCT03502993
|Contact: Jethro Herbergemail@example.com|
|Contact: R Galassinifirstname.lastname@example.org|
|Imperial College London||Recruiting|
|London, United Kingdom, W2 1PG|
|Contact: Rachel Galassini email@example.com|
|Principal Investigator: Michael Levin|
|Principal Investigator: Herberg Jethro|
|Study Chair:||Michael Levin||Imperial College London|