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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVestre Viken Hospital Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rapid diagnostics

    Device

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Standard diagnosticsNo intervention 0 interventions
Group B: Rapid diagnosticsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Improve microbiological sampling strategies in AECOPD.

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

Time frame
Within months to a year after study completion.
2

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

Time to targeted antimicrobial therapy in hours.

Time frame
Within months to a year after study completion.
3

Reduce the use of unnecessary broad antimicrobial therapy.

Proportion of patients with AECOPD who receive targeted antimicrobial therapy.

Time frame
Within months to a year after study completion.
4

Increase knowledge of the microbiological etiology in AECOPD.

Microbiological etiology in AECOPD.

Time frame
Within months to a year after study completion.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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