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NCT Number: NCT06105814

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Exacerbation Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid diagnostics

Device

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

Primary outcomes

  1. Improve microbiological sampling strategies in AECOPD.

    Time frame: Within months to a year after study completion.

    Proportion of AECOPD with a microbiologically verified diagnosis from sputum versus nasopharyngeal swab.

  2. Improve microbiological diagnostic workflow for faster initiation of adequate antibiotic therapy.

    Time frame: Within months to a year after study completion.

    Time to targeted antimicrobial therapy in hours.

  3. Reduce the use of unnecessary broad antimicrobial therapy.

    Time frame: Within months to a year after study completion.

    Proportion of patients with AECOPD who receive targeted antimicrobial therapy.

  4. Increase knowledge of the microbiological etiology in AECOPD.

    Time frame: Within months to a year after study completion.

    Microbiological etiology in AECOPD.

  5. Increased understanding of the lung microbiome over time.

    Time frame: 2-5 years after study completion

    Identify differences in lung microbiome over time, both in AECOPD and stabile state.

  6. Biomarkers at protein level

    Time frame: 2-5 years after study completion

    Identifying biomarkers in blood and sputum that can help differentiate between bacterial and non-bacterial AECOPD

  7. Protein markers of the iron metabolism

    Time frame: 2-5 years after study completion

    Identifying dynamics in iron metabolism in light of etiology.

  8. Biomarkers at the transcriptional level

    Time frame: 2-5 years after study completion

    Identifying different transcriptomic profiles in different causes of AECOPD

  9. Biomarkers for predicting outcome

    Time frame: 2-5 years after study completion

    Identifying biomarkers that can predict outcome in AECOPD.

Study contacts

Contact information is provided by the study sponsor or research team.

Karl Erik Müller, MD, PhD

CONTACT

[email protected]

+47 97501475

Lars Heggelund, MD, PhD

CONTACT

[email protected]

+47 48285882

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Registry information

Official study title

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

Acronym: COPEXNOR

Important dates

Study start
2024
Primary completion
2025
Study completion
2030
First posted
Oct 30, 2023
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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