Febrile Infant Diagnostic Assessment and Outcome Study

NCT05259683 | Completed

• 1 other identifier: 278080
• Study Type: observational
• Target: 2,076
• Locations: 1 country
• Sites: 1

Brief 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

Urinary Tract Infections; Meningitis; Sepsis; Bacterial Infections

Outcome Measures

Primary Outcomes (3)

• Urinary Tract Infection

  Urinary Tract Infection (UTI) will be confirmed by \>100,000 CFU/ml of a single organism from a single clean urine (clean catch, suprapubic aspiration, urethral catheter specimen) or \>100,000 CFU/ml of the same single organism from two non-clean urine samples (pads, bags, cotton wool) and pyuria (\>5 white blood cells per high-powered field) on laboratory microscopy.

  7 days of attendance

• Bacterial Meningitis

  Meningitis will be confirmed by culture or molecular testing of cerebrospinal fluid (CSF).The reference standard test will be performed by staff blinded to the clinical data and suspected diagnosis.

  7 days of attendance

• Bacteriaemia

  Bacteremia will be confirmed by bacterial culture or molecular testing of blood using quantitative polymerase chain reaction. The reference standard test will be performed by staff blinded to the clinical data and suspected diagnosis.

  7 days of attendance

Eligibility Criteria

• Age: Up to 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants attending paediatric emergency care in the United Kingdom and Ireland

You may qualify if:

• All infants 90 days of age and under with a fever of greater than 38 Centigrade during their time in the Emergency Department (ED) or Assessment Unit (AU) or with a history of fever of greater than 38 Centigrade recorded by anyone via any thermometer type within the last 24 hours.

You may not qualify if:

• None

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (1)

Queen's University Belfast

Belfast, Antrim, BT9 7BL, United Kingdom

Location

Related Publications (4)

• Umana E, Mills C, Norman-Bruce H, Mitchell H, McFetridge L, Lynn F, McKeeman G, Foster S, Barrett MJ, Roland D, Lyttle MD, Watson C, Waterfield T; Paediatric Emergency Research in the UK and Ireland (PERUKI). Performance of clinical decision aids (CDA) for the care of young febrile infants: a multicentre prospective cohort study conducted in the UK and Ireland. EClinicalMedicine. 2024 Nov 27;78:102961. doi: 10.1016/j.eclinm.2024.102961. eCollection 2024 Dec.

  PMID: 39677360 DERIVED

• Evans J, Umana E, Waterfield T; FIDO Study Group in collaboration with PERUKI. Respiratory viral testing for young febrile infants presenting to emergency care: a planned secondary analysis of the Febrile Infants Diagnostic assessment and Outcome (FIDO) prospective observational cohort study. Arch Dis Child. 2024 Nov 19;109(12):988-993. doi: 10.1136/archdischild-2024-327567.

  PMID: 39357988 DERIVED

• Wilson K, Umana E, McCleary D, Waterfield T, Woolfall K. Exploring communication preferences and risk thresholds of clinicians and parents of febrile infants under 90 days presenting to the emergency department: a qualitative study. Arch Dis Child. 2024 Oct 18;109(11):886-893. doi: 10.1136/archdischild-2023-326727.

  PMID: 38986575 DERIVED

• Umana E, Mills C, Norman-Bruce H, Wilson K, Mitchell H, McFetridge L, Woolfall K, Lynn FA, McKeeman G, Foster S, Barrett M, Roland D, Lyttle MD, Watson C, Waterfield T. Applying clinical decision aids for the assessment and management of febrile infants presenting to emergency care in the UK and Ireland: Febrile Infant Diagnostic Assessment and Outcome (FIDO) Study protocol. BMJ Open. 2023 Sep 20;13(9):e075823. doi: 10.1136/bmjopen-2023-075823.

  PMID: 37730397 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

1ml of residual blood plasma collected during routine phlebotomy

MeSH Terms

Conditions

Urinary Tract Infections; Meningitis; Sepsis; Bacterial Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neuroinflammatory Diseases; Nervous System Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses

Study Officials

• Thomas Waterfield, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 28, 2022
• Study Start: August 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

GB (1)