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Not yet recruiting NCT06105814

Improved Diagnostics, Treatment and Follow-up of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

No phase Interventional Chronic Obstructive Pulmonary Disease Exacerbation Pneumonia Respiratory Tract Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rapid diagnostics.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease Exacerbation, Pneumonia, Respiratory Tract Infections. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Improved Diagnostics, Treatment and Follow-up of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPEXNOR)

Overview

Chronic obstructive pulmonary disease (COPD) is a chronic and often progressive pulmonary disease, where inflammation and recurrent infections are key pathophysiological contibutors in disease progression. Acute exacerbations of COPD (AECOPD) are often treated with antibiotics, even though only about 50% are caused by bacteria, and the evidence for benefit of empiric antibiotic treatment in AECOPD is conflicting. Microbiological sampling is often insufficient in the setting of AECOPD, and there is a lack of biomarkers distinguishing AECOPD caused by bacteria from those not caused by bacteria, leaving the clinician with few tools to guide the use of antibiotics. Overuse of antibiotics is the main driver of antimicrobial resistance (AMR), a major global public health threat, and obtaining the correct microbiological diagnose is important in guiding treatment of AECOPD. COPEXNOR seeks to examine which samples give the highest microbiological yield in AECOPD, comparing induced sputum to nasopharyngeal swabs. We will also compare conventional microbiological diagnostics to modern rapid molecular microbiological tests, to evaluate if faster microbiological diagnosis improves antibiotic stewardship. The study aims to define the microbiological etiology causing AECOPD in the Norwegian COPD-population, and examine the lung microbiome over time. COPEXNOR will explore biomarkers in sputum and blood that can be useful for differentiating patients who will benefit from antibiotic treatment from patients who will not.

Interventions

  • Device Rapid diagnostics
    Sputum sampes will in addition to standard diagnostics be investigated using a rapid diagnostic plattform (FilmArray)

Primary outcome measures

  • Improve microbiological sampling strategies in AECOPD. [Time frame: Within months to a year after study completion.]
  • Improve microbiological diagnostic workflow for faster initiation of adequate antibiotic therapy. [Time frame: Within months to a year after study completion.]
  • Reduce the use of unnecessary broad antimicrobial therapy. [Time frame: Within months to a year after study completion.]
  • Increase knowledge of the microbiological etiology in AECOPD. [Time frame: Within months to a year after study completion.]
  • Increased understanding of the lung microbiome over time. [Time frame: 2-5 years after study completion]
  • Biomarkers at protein level [Time frame: 2-5 years after study completion]
  • Protein markers of the iron metabolism [Time frame: 2-5 years after study completion]
  • Biomarkers at the transcriptional level [Time frame: 2-5 years after study completion]
  • Biomarkers for predicting outcome [Time frame: 2-5 years after study completion]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years
  • Admitted to the emergency room with a tentative diagnosis of AECOPD, and at least two of the following criteria, more than the daily variation,
  • Increased dyspnea
  • Increased cough
  • Increased sputum production
  • Need for change in medication due to AECOPD
  • Signed informed consent. Among patients with temporal or permanent reduced ability to consent, close relatives and/or family members must be asked and may approve or reject participation on behalf of the patient. In cases where close relatives/family members are not available, study personnel may include patients according to conscious judgment.
  • Patients will be informed about the study and included by dedicated and approved study personnel (study nurses or study doctors), not by the treating health personnel.

Exclusion criteria

  • Pulmonary embolism, segmental or larger
  • Refractory septic shock (meeting the Sepsis-3 definition of septic shock, and requiring vasopressors ≥ 0.5 mcg/kg/min noradrenaline or equivalent dose of other vasopressor(s)
  • Glasgow Coma Scale score 3
  • Patients not eligible for lower airways sampling within the first 24 hours of admission
  • Palliative situation with life expectancy < 1 week

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06105814 · DS-INF-COPEXNOR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗