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Completed

NCT Number: NCT03509727

Procalcitonin in Diagnosis of Bacterial Infections in Young Infants

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

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

Up to 90 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Belfast Hopsital for Sick Children

Belfast, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suspected bacterial infection

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Invasive bacterial infection

    Time frame: 2 days

    Isolation of a bacterial pathogen in blood or cerebrospinal fluid culture

Sponsors and collaborators

Lead sponsor

Belfast Health and Social Care Trust

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 26, 2018
Registry last updated
Apr 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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