Procalcitonin in Diagnosis of Bacterial Infections in Young Infants

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03509727

Enrollment

126

Registered

2018-04-26

Start date

2017-08-01

Completion date

2018-01-01

Last updated

2018-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 90 Days

Inclusion criteria

* Suspected bacterial infection

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
Invasive bacterial infection	2 days	Isolation of a bacterial pathogen in blood or cerebrospinal fluid culture

Countries

United Kingdom

Outcome results