N/A
Completed N=7,247
Personalised Risk Assessment in Febrile Illness to Optimise Real-life Management Across the European Union (PERFORM)
Source: ClinicalTrials.gov NCT03502993 ↗Enrolled (actual)
7,247
Serious AEs
1.7%
Results posted
Oct 2023
Primary outcomePrimary: Number of Participants With Clinically-assigned Retrospective Phenotype — 655; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically-assigned Retrospective Phenotype |
655; 0 | — |
Eligibility Criteria
Inclusion Criteria
- All children 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.
Data sourced from ClinicalTrials.gov (NCT03502993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.