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CompletedNCT03474484Updated Sep 21, 2018

Calprotectin I Serum as a Diagnostic Marker

An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by St. Olavs Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-21.

Sponsored by St. Olavs Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
113
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Pulmonary Disease, Chronic Obstructive

Keywords

  • Biomarkers
  • Sensitivity and Specificity
  • Clinical Deterioration
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In context

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

This study's enrollment of 113 is below the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

St. Olavs Hospital is the lead sponsor of 171 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • known malignant disease
  • bronchiectasis
  • chronic bacterial colonisation of the airways
  • treatment with an drug or long-term treatment with antibiotics.
  • not examined with a chest X-ray at admission
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
113 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. Calprotectin concentration in serum

    ELISA-kit (MRP8/14 ELISA)

    Time frame: Change in serum concentration from baseline to 48 hours

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Study locations

1 site
  • Department of Thoracic and Occupational Medicine
    Trondheim, Trøndelag 7006, Norway
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References and documents

Publications

  • 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. PubMed 26174093 ↗

Individual participant data

Plan to share: Undecided — Depending on the requirements from journal where results of this study will be published

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2018 to primary completion in Sep 2018, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 15, 2018
First posted
Mar 22, 2018
StartActual
Apr 3, 2018
Primary completionActual
Sep 14, 2018
CompletionActual
Sep 14, 2018
Last update
Sep 21, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03474484
Lead sponsor
St. Olavs Hospital
Responsible party
Sponsor
First posted
Mar 22, 2018
Start date
Apr 3, 2018
Primary completion
Sep 14, 2018
Completion
Sep 14, 2018
Last update
Sep 21, 2018

Study contacts

Anne h. Henriksen, md phd
study director · St Olavs Hospital HF

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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