Procalcitonin-guided Treatment Regarding Antibiotic Use for Acute COPD Exacerbations: a Prospective Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COPD Exacerbation
- Sponsor
- Erasmus Medical Center
- Enrollment
- 693
- Locations
- 11
- Primary Endpoint
- Treatment failure
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This study the investigators will examine whether procalcitonin-guided treatment regarding antibiotic therapy is non-inferior to usual care in patients who are admitted because of an acute COPD exacerbation when it comes to treatment failure on day 30.
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a prevalent disease, worldwide, and in the Netherlands with approximately 600.000 patients. COPD is currently the 3rd leading cause of death worldwide and is also a leading cause of disability-adjusted life years. Given the contribution of exacerbations both to loss in quality of life and to health-care costs, it is of paramount importance to improve the current treatment of exacerbations. Pulmonary physicians are well aware of overuse of antibiotics, but lack the tools to decide which medication to give in the clinical setting. Biomarkers may aid towards a more personalized treatment of acute COPD exacerbations (AECOPD). Procalcitonin (PCT), the precursor of calcitonin, is released in response to a bacterial infection by many tissues within 6-12 hours after the onset of infection, while the concentration is only minimally raised in viral infections, making it a relative specific diagnostic tool for bacterial infection. Several trials have shown a reduction in antibiotic consumption in AECOPD when using a PCT-guided treatment algorithm. Recent systematic reviews concluded that appropriately powered trials are lacking to confirm that clinical outcomes are comparable with usual care. In this study the investigators will examine whether a PCT-guided treatment regarding antibiotic therapy is non-inferior to usual care in patients who are admitted because of an acute COPD exacerbation when it comes to treatment failure on day 30.
Investigators
Menno M. van der Eerden
Principal investigator and Pulmonologist
Erasmus Medical Center
Eligibility Criteria
Inclusion Criteria
- •COPD, according to GOLD 2018 definition
- •Indication for hospitalization because of acute severe exacerbation of COPD, as defined by GOLD 2018 and modified Anthonisen criteria
- •Presence of at least 2 major symptoms of the modified Anthonisen criteria (acute deterioration in sputum volume, sputum purulence and dyspnea) or the presence of 1 major symptom and 1 minor symptom (coughing, wheeze, nasal discharge, sore throat, fever)
- •Post-bronchodilator FEV1/FVC \< 0,70 and FEV1% \< 80%pred. within last 5 years
- •At least 40 years
- •Smokers or ex-smokers with \> 10 packyears
- •Written informed consent
- •Start of symptoms no more than 7 days before admission
Exclusion Criteria
- •Indication for ICU and or non-invasive ventilation \< 72h of admission
- •Pneumonia, radiologically confirmed
- •Infection at another site and/or sepsis according to the SIRS criteria (with tachycardia and tachypnea not being caused by the exacerbation)
- •COPD before age 40
- •Asthma, without presence of COPD.
- •Patients with COPD , with or without a history of asthma (in childhood or as an adolescent) will NOT be excluded/are allowed to participate.
- •Patients with Asthma/COPD overlap syndrome (with current asthma AND COPD) will NOT be excluded/are allowed to participate.
- •Clinically relevant heart failure or myocardial ischemia
- •Chronic use of immunosuppressants, including prednisolone (a prednisone equivalent of 10mg or less is allowed/is NOT an exclusion criterion)
- •Known bronchiectasis as a primary diagnosis
Outcomes
Primary Outcomes
Treatment failure
Time Frame: 30 days
Treatment failure is defined as disease-related mortality, need for endotracheal intubation or vasopressors, renal failure (defined as Kidney Disease: Improving Global Outcomes (KDIGO) stage 3 - new renal replacement therapy, tripling of baseline creatinine, or serum creatinine \> or = 350 umol/L), lung abcess/empyema, development of pneumonia or rehospitalization within 30 days after inclusion.
Secondary Outcomes
- EQ-5D-5L(change between baseline and day 30)
- Re-exacerbation(30 days)
- CAT(change between baseline and day 30)
- Decision to start antibiotic therapy after an initial opposite decision (after 48 hours)(30 days)
- Incomplete resolution of the clinical signs and symptoms(day 30)
- iMCQ(30 days)
- Cumulative antibiotic consumption(30 days)
- Cumulative prednisolone consumption(30 days)
- Length of hospitalization(up to 30 days)
- Non-invasive ventilation after 72 hours of admission(30 days)
- Time to complete resoluation of symptoms(30 days)
- Modified Anthonisen criteria(day 10)
- Side effects of antibiotic treatment(30 days)
- EXACT respiratory questionnaire(day 30)