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Calprotectin I Serum as a Diagnostic Marker

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03474484
Recruitment Status : Completed
First Posted : March 22, 2018
Last Update Posted : September 21, 2018
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

Study Description
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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).

Condition or disease
Pulmonary Disease, Chronic Obstructive

Study Design
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Study Type : Observational
Actual Enrollment : 113 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Calprotectin I in Serum as a Diagnostic Marker of Pneumonia in Patients Hospitalised With Acute COPD Exacerbation
Actual Study Start Date : April 3, 2018
Actual Primary Completion Date : September 14, 2018
Actual Study Completion Date : September 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Calprotectin concentration in serum [ Time Frame: Change in serum concentration from baseline to 48 hours ]
    ELISA-kit (MRP8/14 ELISA)


Biospecimen Retention:   Samples Without DNA
The standard hospital procedures were followed for collection and processing of blood for the analysis of C-reactive protein (CRP) and white blood cell count (WBC). Additional blood samples for calprotectin were obtained at admission (T0) and 6 (T1), 24 (T2) and 48 (T3) hours post admission. Serum specimens for the calprotectin analysis were stored at minus 70°C until they were analyzed.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474484


Locations
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Norway
Department of Thoracic and Occupational Medicine
Trondheim, Trøndelag, Norway, 7006
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
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Study Director: Anne h. Henriksen, md phd St Olavs Hospital HF
More Information
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Publications:

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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03474484    
Other Study ID Numbers: 20171496/REK midt
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Depending on the requirements from journal where results of this study will be published

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Biomarkers
Sensitivity and Specificity
Clinical Deterioration
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive