Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard diagnostics | No Intervention | Standard microbiological diagnostics, with nasopharyngeal swab and induced sputum or endotracheal aspirate for real-time polymerase chain reaction (PCR) and culture, blood cultures and urinary antigen tests | |
| Rapid diagnostics | Experimental | In addition to standard diagnostics, induced sputum or endotracheal aspirate analyzed with multiplex PCR (FilmArray). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid diagnostics | Device | Sputum sampes will in addition to standard diagnostics be investigated using a rapid diagnostic plattform (FilmArray) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Increase knowledge of the microbiological etiology in AECOPD. | Microbiological etiology in AECOPD. | Within months to a year after study completion. |
| 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 |
| 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 |
| Protein markers of the iron metabolism | Identifying dynamics in iron metabolism in light of etiology. |
Not provided
Not provided
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,
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars Heggelund, MD, PhD | Contact | +47 48285882 | lars.heggelund@vestreviken.no | |
| Karl Erik Müller, MD, PhD | Contact | +47 97501475 | kamull@vestreviken.no |
| Name | Affiliation | Role |
|---|---|---|
| Lars Heggelund, MD, PhD | Medical department, Drammen hospital, Vestre Viken. Department of clinical science, faculty of medicine, University of Bergen. | Principal Investigator |
| Karl Erik Müller, MD, PhD | Medical department, Drammen hospital, Vestre Viken. Department of clinical science, faculty of medicine, University of Bergen. |
Not provided
Research data is likely to be made avaliable upon reasonable request. It has to be anonymized due to national regulations.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000092025 | Rapid Diagnostic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided
COPEXNOR is a prospective, randomized controlled trial with two arms: (1) Standard microbiological diagnostics, with nasopharyngeal swab and induced sputum or endotracheal aspirate for real-time polymerase chain reaction (PCR) and culture, blood cultures and urinary antigen tests, and (2) in addition to (i), induced sputum or endotracheal aspirate analyzed with multiplex PCR (FilmArray).
Not provided
Not provided
Not provided
| 2-5 years after study completion |
| Biomarkers at the transcriptional level | Identifying different transcriptomic profiles in different causes of AECOPD | 2-5 years after study completion |
| Biomarkers for predicting outcome | Identifying biomarkers that can predict outcome in AECOPD. | 2-5 years after study completion |
| Study Director |
| D000067716 | Point-of-Care Testing |
| D019095 | Point-of-Care Systems |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |