NCT05854901Completed
PCT-guided Treatment Regarding Antibiotic Use for Acute COPD Exacerbations
Procalcitonin-guided Treatment Regarding Antibiotic Use for Acute COPD Exacerbations: a Prospective Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
This study the investigators will examine whether procalcitonin-guided treatment regarding antibiotic therapy is non-inferior to usual care in patients who are admitted because of an acute COPD exacerbation when it comes to treatment failure on day 30.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 693 (actual)
- First submitted
- 14 Feb 2023
- Start date
- 10 Aug 2021
- Primary completion date
- 6 Aug 2026
- Lead sponsor
- Erasmus Medical Center
- Diseases
- COPD
- NCT number
- NCT05854901
What you commit to
- Study type: Interventional
- Participants enrolled: 693
- From 10 Aug 2021 to the primary completion date, 6 Aug 2026
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Infection at another site and/or sepsis according to the SIRS criteria (with tachycardia and tachypnea not being caused by the exacerbation)
- 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
Age
- COPD before age 40
Other
- Indication for ICU and or non-invasive ventilation \< 72h of admission
- Pneumonia, radiologically confirmed
- 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)
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Noordwest hospital group Coordinator of this site? Confirm its status | Alkmaar | Netherlands | Unknown status |
| OLVG Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Amphia Hospital Coordinator of this site? Confirm its status | Breda | Netherlands | Unknown status |
| Catharina hospital Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Unknown status |
| MST Enschede Coordinator of this site? Confirm its status | Enschede | Netherlands | Unknown status |
| Groene Hart Coordinator of this site? Confirm its status | Gouda | Netherlands | Unknown status |
| Zuyderland hospital Coordinator of this site? Confirm its status | Heerlen | Netherlands | Unknown status |
| Bravis Hospital Coordinator of this site? Confirm its status | Roosendaal | Netherlands | Unknown status |
| Erasmus MC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Franciscus Gasthuis & Vlietland Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Isala Klinieken Coordinator of this site? Confirm its status | Zwolle | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.