Value of PCT When Diagnosing Candidemia | NCT05385107

Studies
Value of PCT When Diagnosing Candidemia

NCT05385107

Sponsor

Karolinska University Hospital

Status

Completed

Last Update Posted

May 23, 2022Actual

Enrollment

49Actual

Phase

Not provided

Conditions

The Value of Procalcitonin in Patients With Suspected Candidemia

Interventions

Serum procalcitonin concentration

Countries

Sweden

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

May 2022

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

Apr 1, 2010Actual

Primary Completion Date

Dec 31, 2015Actual

Completion Date

Dec 12, 2021Actual

First Submitted Date

Dec 12, 2021

First Submission Date that Met QC Criteria

May 19, 2022

First Posted Date

May 23, 2022Actual

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

May 19, 2022

Last Update Posted Date

May 23, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Johan Petersson, Associate Profesor, Senior Consultant, Karolinska University HospitalPrincipal Investigator

Lead Sponsor

Karolinska University HospitalOTHER

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

This study is a retrospective analysis to identify and compare the shift in inflammatory biomarkers in ICU patients immediately before and after the first identification of candidemia.

Detailed Description

As above.

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

49Actual

Name	Type	Description	Arm Group Labels	Other Names
Serum procalcitonin concentration	Diagnostic Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Absolute procalcitonin concentration		9 days
Shift (trend) procalcitonin concentration		9 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria (all has to be fullfilled):

ICU patients with blood cultures showing growth of Candida species
clinical records including daily data on WBC, CRP, Procalcitonin and body temperature

Exclusion Criteria:

Age lower than 18 years
blood cultures with growth of Candida species before ICU admission
incomplete records of daily WBC, CRP, Procalcitonin or body temperature

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Intensive care patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital Solna		Stockholm		17176	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

No plan

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided