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NCT03509727 Clinical Trial

Procalcitonin in Diagnosis of Bacterial Infections in Young Infants

Sepsis Clinical Trial

Official title:
Point-of-care-testing for Procalcitonin in Diagnosis of Bacterial Infections in Young Infants: a Diagnostic Accuracy Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03509727
Other study ID # PCT
Secondary ID
Status Completed
Phase
First received April 17, 2018
Last updated April 17, 2018
Start date August 1, 2017
Est. completion date January 1, 2018

Study information
Verified date April 2018
Source Belfast Health and Social Care Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 126
Est. completion date January 1, 2018
Est. primary completion date January 1, 2018
Accepts healthy volunteers
Gender All
Age group N/A to 90 Days
Eligibility Inclusion Criteria:

- Suspected bacterial infection

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Royal Belfast Hopsital for Sick Children Belfast

Sponsors (1)
Lead Sponsor Collaborator
Belfast Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Invasive bacterial infection Isolation of a bacterial pathogen in blood or cerebrospinal fluid culture 2 days
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