COPD COPD, chronic obstructive pulmonary disease
Conditions
Interventions
het gebruiken van de concentratie procalcitonine in het bloed om te bepalen of een patient met COPD antibiotica nodig heeft of niet
Sponsors
ZonMW
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - COPD (volgens GOLD 2018) - Opname indicatie AECOPD - Klinische exacerbatie COPD - FEV1/FVC < 0.70 en een FEV1 < 80% van voorspeld in de laatste 5 jaar, of mogelijkheid tot longfunctie achteraf - Rokers of ex-rokers met tenminste 10 pack years - Toename van (meestal chronische) symptomen max 7 dagen voor opname
Exclusion criteria
Exclusion criteria: - IC-opname of NIV < 72 uur na opname - Recente exacerbatie (<28 dg) - Pneumonie (radiologisch bevestigd) of infectie elders - Sepsis (SIRS: waarbij tachycardie/-pneu niet door AECOPD komen) - Astma zonder aanwezigheid COPD. - Klinisch relevant hartfalen of myocardischemie - Chronisch gebruik van immuunsuppressiva (Prednison onderhoud t/m 10 mg is WEL toegestaan) - Bronchiëctasieën als primaire diagnose - Kolonisatie met P. aeruginosa (of ander micro-organisme ongevoelig voor augmentin) - Zwangerschap
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to show that at hospitalization for a severe exacerbation of COPD, PCT-guided treatment regarding antibiotic use is non-inferior to usual care consisting of prednisolone and or antibiotics, in terms of treatment failure at day 30 for patients hospitalized because of an acute exacerbation of COPD (AECOPD). Treatment failure is defined as disease-related mortality, need for endotracheal intubation or vasopressors, renal failure, lung abcess/empyema, development of pneumonia or rehospitalization within 30 days after inclusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary outcome: Treatment failure is defined as an incomplete resolution of the clinical signs and symptoms associated with the AECOPD at day 30 after inclusion of the study (i.e not reaching the baseline condition prior to the AECOPD). The other secondary objectives are: · Change in Quality of Life on day 1, 10, and after 30 days using the COPD Assessment Test (CAT) · EXACT – Respiratory symptoms scale (at admission, at day 10 and at day 30 after admission) · Time to complete resolution of symptoms according to daily symptom diaries evaluating the modified Anthonisen criteria · Decision to start antibiotic therapy after an initial opposite decision (after 48 hours) · Side effects (gastro-intestinal complaints, allergic reactions) · Cumulative antibiotic consumption · Cumulative prednisolone consumption · Length of hospitalization · Re-exacerbation within 30 days · Non-Invasive ventilation after 72 hours of admission Cost-effectiveness analysis Alongside the clinical trial, an economic evaluation will be performed conform the guidelines of the Health Care Institute Netherlands (17). For this we will use a patient’s self-reported questionnaire, which is based on an adapted version of the iMTA Medical Consumption Questionnaire (iMCQ). The difference in total costs between the two groups will be related to the difference in the following outcomes: QALYs, treatment failures and CAT (COPD Assessment Test). The utilities to calculate QALYs will be measured with the EQ-5D-5L with and without the respiratory bolt-on. | — |
Contacts
Public ContactMichael van Schaik
Erasmus Medical Center
Outcome results
None listed