Calprotectin I Serum as a Diagnostic Marker | NCT03474484

Studies
Calprotectin I Serum as a Diagnostic Marker

NCT03474484

Sponsor

St. Olavs Hospital

Status

Completed

Last Update Posted

Sep 21, 2018Actual

Enrollment

113Actual

Phase

Not provided

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Not provided

Countries

Norway

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

Sep 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

Apr 3, 2018Actual

Primary Completion Date

Sep 14, 2018Actual

Completion Date

Sep 14, 2018Actual

First Submitted Date

Mar 15, 2018

First Submission Date that Met QC Criteria

Mar 15, 2018

First Posted Date

Mar 22, 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

Sep 20, 2018

Last Update Posted Date

Sep 21, 2018Actual

Name	Class
Norwegian University of Science and Technology	OTHER

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

Lower respiratory tract infection is the most common cause of acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Patients diagnosed with pneumonia in addition to an AECOPD experience more severe clinical and laboratory disease manifestations, increase in-hospital morbidity and worse outcome. Clinicians have sought for new biomarkers that together with clinical assessments can improve the diagnostic accuracy of pneumonia in patients with AECOPD.The aim of the present study is to compare the accuracy of calprotectin with procalcitonin (PCT), C-reactive protein (CRP) and white blood cell count (WBC).

Detailed Description

Not provided

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

Retention

Enrollment

113Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
np-AECOPD		Patients with evidence of acute exacerbation of chronic obstructive pulmonary disorder (AECOPD) and pulmonary infiltrate on chest X -ray at admission
p-AECOPD		Patients with evidence of acute exacerbation of chronic obstructive pulmonary disorder (AECOPD) without pulmonary infiltrate on chest X -ray at admission

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Calprotectin concentration in serum	ELISA-kit (MRP8/14 ELISA)	Change in serum concentration from baseline to 48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinically confirmed acute exacerbation of chronic obstructive pulmonary disorder (AECOPD)
COPD diagnosis previously confirmed by spirometry according to the GOLD criteria.

Exclusion Criteria:

known malignant disease
bronchiectasis
chronic bacterial colonisation of the airways
treatment with an immunosuppressive drug or long-term treatment with antibiotics.
not examined with a chest X-ray at admission

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

Patients admitted to the Department of Thoracic Medicine at Trondheim University Hospital (TUH) due to an AECOPD, age > 18years old. (EU). The patients were examined at the Emergency Unit and included in the study if they had a COPD diagnosis previously confirmed by spirometry according to the GOLD criteria and a clinically confirmed AECOPD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne h. Henriksen, md phd	St Olavs Hospital HF	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Thoracic and Occupational Medicine		Trondheim	Trøndelag	7006	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26174093	Background	Titova E, Aune MW, Fonn K, Henriksen AH, Asberg A. Neutrophil CD64 Expression as a Diagnostic Marker in Patients Hospitalized with Exacerbations of COPD: A Prospective Observational Study. Lung. 2015 Oct;193(5):717-24. doi: 10.1007/s00408-015-9762-2. Epub 2015 Jul 15.

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D006967	Hypersensitivity
D000075902	Clinical Deterioration

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease