Procalcitonin-Guided Treatment Regarding Antibiotic Use for Acute COPD Exacerbations (PRECISION): Study Protocol for a Prospective Randomized Controlled Trial

Autor: Michael van Schaik, Hans in 't Veen, Guy Brusselle, Wim Boersma, Paul Bresser, Monique Reijers, Yordi van Dooren, Remco Djamin, Marloes de Vries - van Melle, Jan Willem van den Berg, Maureen Rutten - van Mölken, Eric (H) Boersma, Menno van der Eerden, Joachim Aerts
Rok vydání: 2022
Popis: Background: Chronic Obstructive Pulmonary Disease (COPD) is a worldwide prevalent disease. It is estimated to be the 3rd leading cause of death worldwide in 2020, and it is also a leading cause of disability-adjusted life years (DALY’s). COPD accounts for just over 3% of the total health care budget in the European Union. The majority of these costs are attributed to acute exacerbations of COPD (AECOPD). Given the contribution of exacerbations, it is of paramount importance to improve the current treatment of exacerbations to reduce the burden of disease for patients (mortality and DALY’s) and for society (costs). Treatment of AECOPD generally consists of corticosteroids and antibiotics, mostly in one-size fits all fashion. Pulmonary physicians are well aware of overuse of antibiotics, but lack the tools to decide which medication to give. Biomarkers may aid towards a more personalized treatment of AECOPD by identifying which patient would benefit from antibiotics. Procalcitonin (PCT) is the precursor of calcitonin and is released in response to a bacterial infection. PCT levels are minimally raised in viral infections, making it a relative specific diagnostic tool for bacterial infections. Several trials have shown a reduction in antibiotic consumption in AECOPD when using a PCT-guided treatment algorithm. One meta-analysis suggested that PCT-based protocols may be superior to standard care, but the authors stated that appropriately powered confirmatory trials are necessary. The objective of our study is to assess that at hospitalization for a severe AECOPD, PCT-guided treatment to guide antibiotic administration is non-inferior to usual care, in terms of treatment failure at day 30. Methods: The study is set up as a prospective randomized trial. A total of 693 patients with a severe exacerbation of COPD will be included and randomized between usual care and PCT-guided treatment regarding antibiotic therapy. The primary endpoint will be treatment failure within 30 days after inclusion, the endpoint comprises disease-related mortality and other disease-related adverse events. Discussion: We believe this trial can add to the currently available evidence with PCT being tested in a clinical setting in a treatment algorithm specifically in COPD with the primary objective being treatment failure. Trial registration: Netherlands Trial Register. Registration number: NL9122. Date of registration: 24-11-2020. URL of trial registry record: https://www.trialregister.nl/trial/9122
Databáze: OpenAIRE