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Febrile Infant Diagnostic Assessment and Outcome Study

NCT05259683 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2076

Last updated 2024-02-16

No results posted yet for this study

Summary

Febrile infants under 3 months of age represent a high risk group for invasive bacterial infection (IBI) and UTI with approximately 10-20% having bacteremia, meningitis or urinary tract infection. The assessment of febrile infants is challenging, and current National Institute for Health and Care Excellence (NICE) guidance advocates a cautious approach with the majority of infants requiring a septic screen, parenteral broad-spectrum antibiotics, and admission to hospital. Internationally there is significant variation in the approach to febrile infants with European and USA guidance advocating a tailored approach based on clinical features and biomarker testing. None of the available clinical decision aids (CDA) have been validated in a UK and Irish cohort. The main objectives of the FIDO study are to report performance accuracy of CDA in a UK (United Kingdom) and Irish population, and describe the aetiology of SBI in young infants.

The FIDO study is a prospective observational cohort study of infants under 90 days of age with a measured fever greater than 38 Centrigrade within 24 hours of presentation. The study will run for approximately 12 months and recruit a minimum of 1000 participants.Symptoms, clinical features and laboratory results will be recorded on an electronic case report form (CRF) by the attending clinician.

Conditions

Sponsors & Collaborators

  • Queen's University, Belfast

    lead OTHER

Principal Investigators

  • Thomas Waterfield, PhD · Queen's University, Belfast

Eligibility

Max Age
90 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-08-31
Completion
2023-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05259683 on ClinicalTrials.gov