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

Not Applicable

Not yet recruiting

• Conditions: Chronic Obstructive Pulmonary Disease Exacerbation; Respiratory Tract Infections; Pneumonia
• Interventions: Device: Rapid diagnostics

• Registration Number: NCT06105814
• Lead Sponsor: Vestre Viken Hospital Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Last Update Submitted: 2023-10-23
• Study First Posted: 2023-10-30
• Last Update Posted: 2023-10-30
• Study Start: 2024-01-01
• Primary Completion: 2025-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapid diagnostics	Rapid diagnostics	In addition to standard diagnostics, induced sputum or endotracheal aspirate analyzed with multiplex PCR (FilmArray).

Primary Outcome Measures

Name	Time	Method
Protein markers of the iron metabolism	2-5 years after study completion	Identifying dynamics in iron metabolism in light of etiology.
Improve microbiological diagnostic workflow for faster initiation of adequate antibiotic therapy.	Within months to a year after study completion.	Time to targeted antimicrobial therapy in hours.
Reduce the use of unnecessary broad antimicrobial therapy.	Within months to a year after study completion.	Proportion of patients with AECOPD who receive targeted antimicrobial therapy.
Increased understanding of the lung microbiome over time.	2-5 years after study completion	Identify differences in lung microbiome over time, both in AECOPD and stabile state.
Biomarkers at protein level	2-5 years after study completion	Identifying biomarkers in blood and sputum that can help differentiate between bacterial and non-bacterial AECOPD
Biomarkers at the transcriptional level	2-5 years after study completion	Identifying different transcriptomic profiles in different causes of AECOPD
Improve microbiological sampling strategies in AECOPD.	Within months to a year after study completion.	Proportion of AECOPD with a microbiologically verified diagnosis from sputum versus nasopharyngeal swab.
Increase knowledge of the microbiological etiology in AECOPD.	Within months to a year after study completion.	Microbiological etiology in AECOPD.
Biomarkers for predicting outcome	2-5 years after study completion	Identifying biomarkers that can predict outcome in AECOPD.