Procalcitonin in Diagnosis of Bacterial Infections in You... | NCT03509727

Studies
Procalcitonin in Diagnosis of Bacterial Infections in Young Infants

NCT03509727

Sponsor

Belfast Health and Social Care Trust

Status

Completed

Last Update Posted

Apr 26, 2018Actual

Enrollment

126Actual

Phase

Not provided

Conditions

Sepsis

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Jan 1, 2018Actual

Completion Date

Jan 1, 2018Actual

First Submitted Date

Apr 17, 2018

First Submission Date that Met QC Criteria

Apr 17, 2018

First Posted Date

Apr 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2018

Last Update Posted Date

Apr 26, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thomas Waterfield, Dr Thomas Waterfield, Belfast Health and Social Care TrustPrincipal Investigator

Lead Sponsor

Belfast Health and Social Care TrustOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Suspected bacterial infection

Exclusion Criteria:

None

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

90 Days

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Shields	Queen's University, Belfast	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Belfast Hopsital for Sick Children		Belfast			United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30541505	Derived	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.

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes