Calprotectin I Serum as a Diagnostic Marker

September 20, 2018 updated by: St. Olavs Hospital

Calprotectin I in Serum as a Diagnostic Marker of Pneumonia in Patients Hospitalised With Acute COPD Exacerbation

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Trøndelag
      • Trondheim, Trøndelag, Norway, 7006
        • Department of Thoracic and Occupational Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

Investigators

  • Study Director: Anne h. Henriksen, md phd, St Olavs Hospital HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 3, 2018

Primary Completion (ACTUAL)

September 14, 2018

Study Completion (ACTUAL)

September 14, 2018

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

March 15, 2018

First Posted (ACTUAL)

March 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20171496/REK midt

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Depending on the requirements from journal where results of this study will be published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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