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

NCT06105814 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-10-30

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Obstructive Pulmonary Disease Exacerbation
  • Pneumonia
  • Respiratory Tract Infections

Interventions

DEVICE

Rapid diagnostics

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

Sponsors & Collaborators

  • Vestre Viken Hospital Trust

    lead OTHER

Principal Investigators

  • Lars Heggelund, MD, PhD · Medical department, Drammen hospital, Vestre Viken. Department of clinical science, faculty of medicine, University of Bergen.

  • Karl Erik Müller, MD, PhD · Medical department, Drammen hospital, Vestre Viken. Department of clinical science, faculty of medicine, University of Bergen.

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-12-31
Completion
2030-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06105814 on ClinicalTrials.gov