NCT03509727

Brief Summary

A diagnostic accuracy study investigating the accuracy of procalcitonin in diagnosing invasive bacterial infections in your infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

April 17, 2018

Last Update Submit

April 17, 2018

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • Invasive bacterial infection

    Isolation of a bacterial pathogen in blood or cerebrospinal fluid culture

    2 days

Eligibility Criteria

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

All young infants presenting to the emergency department with suspected infection are eligible for testing.

You may qualify if:

  • Suspected bacterial infection

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Belfast Hopsital for Sick Children

Belfast, United Kingdom

Location

Related Publications (1)

  • Waterfield T, Maney JA, Hanna M, Fairley D, Shields MD. Point-of-care testing for procalcitonin in identifying bacterial infections in young infants: a diagnostic accuracy study. BMC Pediatr. 2018 Dec 12;18(1):387. doi: 10.1186/s12887-018-1349-7.

    PMID: 30541505DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Shields

    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
Dr Thomas Waterfield

Study Record Dates

First Submitted

April 17, 2018

First Posted

April 26, 2018

Study Start

August 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

GB(1)