Personalised Risk Assessment in Febrile Illness to Optimise Real-life Management Across the European Union (PERFORM)

Status: Completed
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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. 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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 17
Healthy Volunteers: t
View:

• All children \<18 years with fever \>38ºC, or a history of fever (within 3 days), in whom the attending clinician determines the need for blood sampling or whom parents give consent for bloods taken for research purposes

• All children \<18 years suspected of infection, including the full spectrum of disease severity and co-morbidities.

• Afebrile control children who are having blood tests for reasons other than for investigation of infectious or inflammatory illness.

Locations
Other Locations
United Kingdom
Imperial College London
London
Time Frame
Start Date: 2016-06-02
Completion Date: 2021-12-31
Participants
Target number of participants: 7247
Treatments
BIVA studies - children with fever and/or suspected infection
A minimum of 3,000 children will be recruited to the BIVA-ED (Biomarker Validation in Emergency Department) 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.
BIVA studies - control children without fever or suspicion of infection
Afebrile children \<18 years (16 years depending in the setting) of age who are having blood tests for reasons other than for investigation of infectious or inflammatory illness or whom parents give consent for bloods taken for research purposes. Controls may have a range of clinical presentations including co-morbidities without infection. One set of samples will be taken from controls, no follow up data or samples taken.
Authors
Herberg Jethro, Michael Levin
Sponsors
Collaborators: University Hospital, Paris, University of Liverpool, National and Kapodistrian University of Athens, University of Ljubljana, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, Micropathology Ltd, University of Warwick, University of Oxford, University of Graz, Ludwig-Maximilians - University of Munich, University of Santiago de Compostela, London School of Hygiene and Tropical Medicine, University of Newcastle Upon-Tyne, Riga Stradins University, Servicio Gallego de Salud, Medical Research Council Unit, The Gambia, Stichting Katholieke Universiteit, BioMérieux, University of Bern
Leads: Imperial College London

This content was sourced from clinicaltrials.gov