Febrile Infants - Diagnostic Assessment and Outcome

Urinary Tract Infections Clinical Trial

— FIDO  

Official title:

Febrile Infants - Diagnostic Assessment and Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196192
• Other study ID #: QIP10/12/19HJ
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: May 2021
• Source: Belfast Health and Social Care Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess how clinicians apply guidance in the assessment of febrile infants presenting the the Emergency Department. The measurable outcomes are:

Primary Objective Report the rates of serious and invasive bacterial infections in febrile infants

Secondary Objectives Report on the predictive value of different clinical features for predicting bacterial infections.

Report on the value of biomarkers for predicting serious and invasive bacterial infections.

Assess the performance of clinical practice guidelines for the assessment of febrile infants.

Description:

The assessment of febrile infants is difficult. In the UK and Ireland current guidance advocates that most children under 3 months of age with a fever undergo a full septic screen including lumbar puncture and receive parenteral antibiotics. Approaches in the United States and Europe including the PECARN and StepByStep approach allow for the discharge home of some low risk young infants.

We intend to assess the current approach to febrile infants and compare that to the available clinical practice guidelines. We also intend to determine which clinical and/or laboratory features are most predictive of serious bacterial infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 555
• Est. completion date: May 1, 2021
• Est. primary completion date: March 1, 2021
• Gender: All
• Age group: N/A to 90 Days

Eligibility

Inclusion Criteria:

• Any infant aged 0 to 90 days (inclusive) with a fever of 38 degrees centigrade or higher recorded in the Emergency Department.

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection
• Meningitis
• Meningitis, Bacterial
• Urinary Tract Infections

Locations

Country	Name	City	State
Ireland	Children's Health Ireland	Dublin
United Kingdom	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland
United Kingdom	Bristol Royal Children's Hospital	Bristol
United Kingdom	Royal Hospital for Children Glasgow	Glasgow
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Royal London Hospital	London

Sponsors (7)

Lead Sponsor	Collaborator
Belfast Health and Social Care Trust	Barts & The London NHS Trust, Bristol Royal Hospital for Children, Children's Health Ireland, Royal Belfast Hospital for Sick Children, Royal Hospital for Children Glasgow, University Hospitals, Leicester

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive bacterial infection	Invasive Bacterial Infection (non-contaminant) confirmed by culture or molecular diagnostic testing of a sterile site i.e. blood or cerebrospinal fluid (CSF). Staphylococcus epidermidis, Propionibacterium acnes, Streptococcus viridans, or Diphtheroides were considered contaminants.	seven days
Primary	Serious bacterial infections	Urinary tract infections defined as growth of =100 000 cfu/mL	seven days