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Clinical Trials/NCT04196192
NCT04196192
Completed
Not Applicable

Febrile Infants - Diagnostic Assessment and Outcome

Belfast Health and Social Care Trust6 sites in 2 countries555 target enrollmentMarch 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Meningitis, Bacterial
Sponsor
Belfast Health and Social Care Trust
Enrollment
555
Locations
6
Primary Endpoint
Invasive bacterial infection
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
May 1, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thomas Waterfield

Doctor

Belfast Health and Social Care Trust

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Invasive bacterial infection

Time Frame: seven days

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.

Serious bacterial infections

Time Frame: seven days

Urinary tract infections defined as growth of ≥100 000 cfu/mL

Study Sites (6)

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