PCT-guided Treatment Regarding Antibiotic Use for Acute COPD Exacerbations
NCT ID: NCT05854901
Last Updated: 2023-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
693 participants
INTERVENTIONAL
2021-08-10
2025-02-28
Brief Summary
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Detailed Description
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Pulmonary physicians are well aware of overuse of antibiotics, but lack the tools to decide which medication to give in the clinical setting. Biomarkers may aid towards a more personalized treatment of acute COPD exacerbations (AECOPD). Procalcitonin (PCT), the precursor of calcitonin, is released in response to a bacterial infection by many tissues within 6-12 hours after the onset of infection, while the concentration is only minimally raised in viral infections, making it a relative specific diagnostic tool for bacterial infection. Several trials have shown a reduction in antibiotic consumption in AECOPD when using a PCT-guided treatment algorithm. Recent systematic reviews concluded that appropriately powered trials are lacking to confirm that clinical outcomes are comparable with usual care.
In this study the investigators will examine whether a PCT-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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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PCT-guided treatment
Patients randomized to this arm will only receive antibiotic treatment when the procalcitonin concentration is \> 0.25ug/L.
Procalcitonin
blood test, measuring the concentration of PCT in ug/L
Usual care
Patients randomized to this arm will receive antibiotic treatment based on the physician's decision.
Physician's decision
The physician's decided whether the patient will receive antibiotic treatment or not
Interventions
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Procalcitonin
blood test, measuring the concentration of PCT in ug/L
Physician's decision
The physician's decided whether the patient will receive antibiotic treatment or not
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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
* 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)
40 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Erasmus Medical Center
OTHER
Responsible Party
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Menno M. van der Eerden
Principal investigator and Pulmonologist
Principal Investigators
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Menno M van der Eerden, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Zuyderland hospital
Heerlen, Limburg, Netherlands
Amphia hospital
Breda, North Brabant, Netherlands
Catharina hospital
Eindhoven, North Brabant, Netherlands
Bravis hospital
Roosendaal, North Brabant, Netherlands
Noordwest hospital group
Alkmaar, North Holland, Netherlands
OLVG
Amsterdam, North Holland, Netherlands
MST Enschede
Enschede, Overijssel, Netherlands
Isala klinieken
Zwolle, Overijssel, Netherlands
Groene Hart
Gouda, South Holland, Netherlands
Erasmus MC
Rotterdam, South Holland, Netherlands
Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Netherlands Trial Register registration included in ICTRP
Other Identifiers
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NL9122
Identifier Type: REGISTRY
Identifier Source: secondary_id
NL72662.078.20
Identifier Type: -
Identifier Source: org_study_id
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