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

Pneumonia Clinical Trial

— COPEXNOR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06105814
• Other study ID #: DS-INF-COPEXNOR
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: October 2023
• Source: Vestre Viken Hospital Trust
• Contact: Lars Heggelund, MD, PhD
• Phone: +47 48285882
• Email: lars.heggelund[@]vestreviken.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease Exacerbation
• Disease Progression
• Lung Diseases
• Lung Diseases, Obstructive
• Pneumonia
• Pulmonary Disease, Chronic Obstructive
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust

Outcome

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