Procalcitonin-guided antibiotic therapy in acute exacerbations of chronic obstructive pulmonary disease (COPD) (AECOPD): a randomised trial - The ProCOLD Study

INTERVENTION: At presentation patients will be randomly assigned to the procalcitonin‐guided therapy group or to the standard‐group. In the ProCT‐group, antibiotic therapy will be discouraged (ProCT less than 0.1 ng/ml) or encouraged (ProCT greater than 0.25 ng/ml) based on ProCT levels. In the standard group therapy will be left to the discretion of the treating physician. A standardised work‐up including C‐reactive protein (CRP), white blood cell count (WBC), sputum/bronchoalveolar lavage (BAL) bacteriology, viral serology, blood cultures, spirometry, chest x‐ray and clinical parameters will be undertaken. After 6 months, all patients will be re‐evaluated in regard to clinical and laboratory parameters, spirometry and number of AECOPD. CONDITION: Acute exacerbations of chronic obstructive pulmonary disease (COPD) ; Respiratory ; Chronic obstructive pulmonary disease (COPD) PRIMARY OUTCOME: Antibiotic use (% of patients). SECONDARY OUTCOME: 1. Measures of laboratory and clinical outcome, i.e., serum ProCT and plasma C‐reactive protein levels, leukocyte counts, temperature, oxygen saturation, respiratory rate, pulse rate, blood pressure, quality of life indices, length of hospitalisation, complications during the course of disease until follow‐up in 14 ‐ 21 days (i.e. need for intensive care unit [ICU] stay, death); 2. Recurrence of exacerbation within 6 months after inclusion in the study including hospitalisation, antibiotics and oral steroids need INCLUSION CRITERIA: Patients presenting an acute exacerbation of COPD requiring medical therapy in the emergency station of a university hospital in Switzerland.