PCT-guided Treatment Regarding Antibiotic Use for Acute COPD Exacerbations (PRECISION)
COPD Exacerbation, COPD, Acute Copd Exacerbation
About this trial
This is an interventional diagnostic trial for COPD Exacerbation focused on measuring Procalcitonin
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 Colonisation with Pseudomonas spp. or other micro-organisms in recent cultures (last 60 days) not susceptible to amoxicillin-clavulanic acid Pregnancy Recent exacerbation (last 28 days)
Sites / Locations
- Zuyderland hospital
- Amphia hospitalRecruiting
- Catharina hospital
- Bravis hospital
- Noordwest hospital groupRecruiting
- OLVGRecruiting
- MST Enschede
- Isala kliniekenRecruiting
- Groene HartRecruiting
- Erasmus MC
- Franciscus Gasthuis & VlietlandRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
PCT-guided treatment
Usual care
Patients randomized to this arm will only receive antibiotic treatment when the procalcitonin concentration is > 0.25ug/L.
Patients randomized to this arm will receive antibiotic treatment based on the physician's decision.