NCT04196192

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
555

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

December 10, 2019

Last Update Submit

May 8, 2021

Conditions

Meningitis, BacterialBacterial InfectionsUrinary Tract Infections

Outcome Measures

Primary Outcomes (2)

  • 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

  • Serious bacterial infections

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

    seven days

Study Arms (1)

Group 1

All infants aged 0-90 days (inclusive) undergoing routine assessments for fever without source.

Eligibility Criteria

AgeUp to 90 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants aged 0-90 days (inclusive) with a fever of 38 degrees centigrade or higher recorded in the Emergency Department between the 31/08/2018 and the 01/09/2019.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Children's Health Ireland

Dublin, Ireland

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT126BE, United Kingdom

Location

Bristol Royal Children's Hospital

Bristol, United Kingdom

Location

Royal Hospital for Children Glasgow

Glasgow, United Kingdom

Location

Leicester Royal Infirmary

Leicester, United Kingdom

Location

Royal London Hospital

London, United Kingdom

Location

Related Publications (2)

  • Waterfield T, Foster S, Platt R, Barrett MJ, Durnin S, Maney JA, Roland D, McFetridge L, Mitchell H, Umana E, Lyttle MD; Paediatric Emergency Research in the UK and Ireland (PERUKI). Diagnostic test accuracy of dipstick urinalysis for diagnosing urinary tract infection in febrile infants attending the emergency department. Arch Dis Child. 2022 Dec;107(12):1095-1099. doi: 10.1136/archdischild-2022-324300. Epub 2022 Aug 24.

    PMID: 36002228DERIVED

  • Waterfield T, Lyttle MD, Munday C, Foster S, McNulty M, Platt R, Barrett M, Rogers E, Durnin S, Jameel N, Maney JA, McGinn C, McFetridge L, Mitchell H, Puthucode D, Roland D; Paediatric Emergency Research in the UK and Ireland (PERUKI). Validating clinical practice guidelines for the management of febrile infants presenting to the emergency department in the UK and Ireland. Arch Dis Child. 2022 Apr;107(4):329-334. doi: 10.1136/archdischild-2021-322586. Epub 2021 Sep 16.

    PMID: 34531196DERIVED

MeSH Terms

Conditions

Meningitis, BacterialBacterial InfectionsUrinary Tract Infections

Condition Hierarchy (Ancestors)

Central Nervous System Bacterial InfectionsBacterial Infections and MycosesInfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 10, 2019

First Posted

December 12, 2019

Study Start

March 1, 2020

Primary Completion

March 1, 2021

Study Completion

May 1, 2021

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

Anonymised datasets not containing any personal data will be available after publication

Locations

GB(5)IE(1)