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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
Sponsor:
Collaborators:
Servizo Galego de Saúde
London School of Hygiene and Tropical Medicine
University of Liverpool
University of Newcastle Upon-Tyne
Erasmus Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
National and Kapodistrian University of Athens
Stichting Katholieke Universiteit
University of Graz
University of Ljubljana
Riga Stradiņs University
Medical Research Council Unit, The Gambia
Ludwig-Maximilians - University of Munich
University of Bern
University of Oxford
University Hospital, Paris
Information provided by (Responsible Party):
Imperial College London

Brief 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.

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

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Study Type : Observational
Estimated Enrollment : 54000 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MOFICHE
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
Other: Hospitalisation
BIVA studies
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



Primary Outcome Measures :
  1. MOFICHE study standardised dataset will be collected [ Time Frame: throughout the study over one year ]
    Duration of antimicrobial treatment

  2. 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


Secondary Outcome Measures :
  1. 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)

  2. 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
blood, urine, nasopharyngeal aspirate/throat swab, stool


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children with fever >38ºC, or a history of fever (within 3 days) who requires a blood test for clinical reasons or consents for research bloods to be taken,
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Children from whom parent/legal guardian signed consent is not received
  • For healthy control children only: febrile illness or vaccination within the last 3 weeks.

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): NCT03502993


Contacts
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Contact: Jethro Herberg j.herberg@imperial.ac.uk
Contact: R Galassini r.galassini@imperial.ac.uk

Locations
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United Kingdom
Imperial College London Recruiting
London, United Kingdom, W2 1PG
Contact: Rachel Galassini       r.galassini@imperial.ac.uk   
Principal Investigator: Michael Levin         
Principal Investigator: Herberg Jethro         
Sponsors and Collaborators
Imperial College London
Servizo Galego de Saúde
London School of Hygiene and Tropical Medicine
University of Liverpool
University of Newcastle Upon-Tyne
Erasmus Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
National and Kapodistrian University of Athens
Stichting Katholieke Universiteit
University of Graz
University of Ljubljana
Riga Stradiņs University
Medical Research Council Unit, The Gambia
Ludwig-Maximilians - University of Munich
University of Bern
University of Oxford
University Hospital, Paris
Investigators
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Study Chair: Michael Levin Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03502993     History of Changes
Other Study ID Numbers: REC ref: 16/LO/1684
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Imperial College London:
children
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents