Personalised Risk assessment in Febrile illness to Optimise Real-life Management across the European Union (PERFORM)

Personalised Risk assessment in Febrile illness to Optimise Real-life Management across the European Union (PERFORM) - PERFORM

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43233

Enrollment

1600

Registered

2016-12-14

Start date

2017-02-06

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

febrile illness

Interventions

bacterium versus virus

diagnosis

febrile children

infectious diseases

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: All children

Exclusion criteria

Exclusion criteria: Participation may not lead to an earlier need for blood transfusion.

Design outcomes

Primary

Measure	Time frame
Biomarker discovery study (BIVABI): the identification of a minimal discriminatory biomarker signatures that define febrile diagnoses, including infection (bacterial vs viral), or inflammatory illness. MOFICHE: Primary outcomes: Antibiotic prescription, hospitalization and number/type of investigations. Number of children re-attending within 5 days of the first hospital presentation. BIVA-studies: The identification of (serious) bacterial or viral infection (confirmed by culture and/or molecular microbiology), or inflammatory disease by using new clinical, proteomic and transcriptomic biomarkers. Sensitivity and specificity of the new biomarkers and the added value of new biomarkers to usual clinical signs and diagnostic work up to discriminate viral and bacterial infections in children, including diagnostically challenging groups (immunocompromised patients, patients with inflammatory/rheumatological disorders , severe ill patients at intensive care departments). Airway device: Percentage of children in which collection and analysis of exhaled air using the Aeonose device was successful.	—

Measure

Time frame

Biomarker discovery study (BIVABI): the identification of a minimal discriminatory biomarker signatures that define febrile diagnoses, including infection (bacterial vs viral), or inflammatory illness. MOFICHE: Primary outcomes: Antibiotic prescription, hospitalization and number/type of investigations. Number of children re-attending within 5 days of the first hospital presentation. BIVA-studies: The identification of (serious) bacterial or viral infection (confirmed by culture and/or molecular microbiology), or inflammatory disease by using new clinical, proteomic and transcriptomic biomarkers. Sensitivity and specificity of the new biomarkers and the added value of new biomarkers to usual clinical signs and diagnostic work up to discriminate viral and bacterial infections in children, including diagnostically challenging groups (immunocompromised patients, patients with inflammatory/rheumatological disorders , severe ill patients at intensive care departments). Airway device: Percentage of children in which collection and analysis of exhaled air using the Aeonose device was successful.

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Secondary

Measure	Time frame
BIVABI study: identification of minimal biomarker signatures that discriminate children with febrile illness on the basis of their severity MOFICHE: Secondary outcome: number of prescriptions of broad spectrum antibiotics versus the number of prescription of narrow spectrum antibiotics (dose in 24 hours). Clinical and general characteristics of antibiotic prescription, hospitalization duration of stay and investigations. BIVA-studies: Secondary: The identification of biomarkers predictive of disease severity in children with bacterial and viral infection, using a combination of clinical phenotypic markers and proteomic and transcriptomic biomarker signature discovery.	—

Measure

Time frame

BIVABI study: identification of minimal biomarker signatures that discriminate children with febrile illness on the basis of their severity MOFICHE: Secondary outcome: number of prescriptions of broad spectrum antibiotics versus the number of prescription of narrow spectrum antibiotics (dose in 24 hours). Clinical and general characteristics of antibiotic prescription, hospitalization duration of stay and investigations. BIVA-studies: Secondary: The identification of biomarkers predictive of disease severity in children with bacterial and viral infection, using a combination of clinical phenotypic markers and proteomic and transcriptomic biomarker signature discovery.

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Countries

Austria, Gambia, Germany, Greece, Latvia, Netherlands, Slovenia, Spain, Switzerland, United Kingdom

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)