Procalcitonin-guided treatment regarding antibiotic use for acute COPD exacerbations: a prospective randomised controlled trial

Recruiting

• Conditions: COPD flare-up; exacerbation COPD; 10021879; 10006436

• Registration Number: NL-OMON55985
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 693

Inclusion Criteria

- COPD, according to GOLD 2018 definition
- Hospitalization because of severe acute exacerbation of COPD
- Post-bronchodilator FEV1/FVC < 0,70 and FEV1% < 80%pred. within last 5 years
or a lung function within 2 months after the index admission that meets these
criteria
- At least 40 years of age
- Smokers or ex-smokers with > 10 packyears
- Written informed consent
- Start of symptoms no more than 7 days before admission
- 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)

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.
o Patients with COPD , with or without a history of asthma (in
childhood or as an adolescent)
will NOT be excluded.
o Patients with Asthma/COPD overlap syndrome (with current asthma AND
COPD) will NOT
be excluded.
- Clinically relevant heart failure or myocardial ischemia
- Chronic use of immunosuppressants, including prednisolone (a prednisolone
equivalent of 10mg or less is allowed/will NOT be excluded)
- Known bronchiectasis as 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to show that at hospitalization for a<br /><br>severe exacerbation of COPD, PCT-guided treatment regarding antibiotic use is<br /><br>non-inferior to usual care consisting of prednisolone and or antibiotics, in<br /><br>terms of treatment failure at day 30 for patients hospitalized because of an<br /><br>acute exacerbation of COPD (AECOPD). Treatment failure is defined as<br /><br>disease-related mortality, need for endotracheal intubation or vasopressors,<br /><br>renal failure*, lung abcess/empyema, development of pneumonia or<br /><br>rehospitalization within 30 days after inclusion.<br /><br><br /><br>*renal failure is defined as Kidney Disease: Improving Global Outcomes (KDIGO)<br /><br>stage 3 - new renal replacement therapy, tripling of baseline creatinine, or<br /><br>serum creatinine >= 350 umol/L. </p><br>