Procalcitonin in Diagnosis of Bacterial Infections in Young Infants

Completed

• Conditions: Sepsis

• Registration Number: NCT03509727
• Lead Sponsor: Belfast Health and Social Care Trust

Brief Summary

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

Detailed Description

The primary aim of this study was to report on the diagnostic accuracy of procalcitonin in the diagnosis of bacterial infections in young infants. This included invasive bacterial infections; defined as the isolation of a bacterial pathogen in blood or cerebrospinal fluid culture.

We conducted a prospective observational diagnostic accuracy study. Young infants less than 90 days of age presenting to the Royal Belfast Hospital for Sick Children with signs of possible bacterial infection were eligible for inclusion. Eligible infants underwent procalcitonin testing using 0.5ml of whole blood with a BRAHMS assay on the Samsung LABGEO IB10® analyser.

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Status Verified: 2018-04
• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-04-17
• Last Update Submitted: 2018-04-17
• Study First Posted: 2018-04-26
• Last Update Posted: 2018-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Suspected bacterial infection

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Invasive bacterial infection	2 days	Isolation of a bacterial pathogen in blood or cerebrospinal fluid culture

Trial Locations

Locations (1)

Royal Belfast Hopsital for Sick Children; 🇬🇧 Belfast, United Kingdom