COPD ExacerbationPRECISIONNCT05854901
PCT-guided Treatment Regarding Antibiotic Use for Acute COPD Exacerbations
A study testing Procalcitonin and Physician's decision in people with COPD Exacerbation and COPD, run by Erasmus Medical Center at 11 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation, COPD, Acute Copd Exacerbation
- What is being tested?
- Procalcitonin and Physician's decision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 693 participants
- Where
- 11 sitesNetherlands
- Study dates
- 10 Aug 2021to 6 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- Patients with COPD , with or without a history of asthma (in childhood or as an adolescent) will NOT be excluded/are allowed to participate.
Show all 13Show fewer
- 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)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Netherlands11 sites
Noordwest hospital group
Alkmaar, North Holland, 1800AM
OLVG
Amsterdam, North Holland, 1091AC
Amphia hospital
Breda, North Brabant, 4818CK
Catharina hospital
Eindhoven, North Brabant, 5623 EJ
MST Enschede
Enschede, Overijssel, 7500KA
Groene Hart
Gouda, South Holland, 2803HH
Zuyderland hospital
Heerlen, Limburg, 6419PC
Bravis hospital
Roosendaal, North Brabant, 4708AE
Erasmus MC
Rotterdam, South Holland, 3015GD
Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, 3045PM
Isala klinieken
Zwolle, Overijssel, 8025 AB
About this study
Official title: Procalcitonin-guided Treatment Regarding Antibiotic Use for Acute COPD Exacerbations: a Prospective Randomised Controlled Trial
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.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a prevalent disease, worldwide, and in the Netherlands with approximately 600.000 patients. COPD is currently the 3rd leading cause of death worldwide and is also a leading cause of disability-adjusted life years. Given the contribution of exacerbations both to loss in quality of life and to health-care costs, it is of paramount importance to improve the current treatment of exacerbations.
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
- COPD Exacerbation, COPD, Acute Copd Exacerbation
- Being tested
- Procalcitonin, Physician's decision
- Keywords
- Procalcitonin
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProcalcitoninDiagnostic test
Also called PCT
blood test, measuring the concentration of PCT in ug/L
Physician's decisionOther
The physician's decided whether the patient will receive antibiotic treatment or not
| Study group | Role | What they receive |
|---|---|---|
| PCT-guided treatment | Experimental | Patients randomized to this arm will only receive antibiotic treatment when the procalcitonin concentration is > 0.25ug/L. Receives: Diagnostic Test: Procalcitonin |
| Usual care | Active comparator | Patients randomized to this arm will receive antibiotic treatment based on the physician's decision. Receives: Other: Physician's decision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
Treatment failure is defined as disease-related mortality, need for endotracheal intubation or vasopressors, renal failure (defined as Kidney Disease: Improving Global Outcomes (KDIGO) stage 3 - new renal replacement therapy, tripling of baseline creatinine, or serum creatinine > or = 350 umol/L), lung abcess/empyema, development of pneumonia or rehospitalization within 30 days after inclusion.
Measured: 30 days
Secondary outcomes (28)
Incomplete resolution of the clinical signs and symptoms
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) scored using the modified Anthonisen criteria
Measured: change between baseline and after 30 days
Incomplete resolution of the clinical signs and symptoms
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) scored using the modified Anthonisen criteria
Measured: day 30
Modified Anthonisen criteria
Patients fill in the modified Anthonisen criteria card on day 1 as a baseline measure
Measured: baseline
Modified Anthonisen criteria
Patients fill in the modified Anthonisen criteria card on day 3
Measured: day 3
Modified Anthonisen criteria
Patients fill in the modified Anthonisen criteria card on day 1 as a baseline measure
Measured: day 5
Modified Anthonisen criteria
Patients fill in the modified Anthonisen criteria card on day 1 as a baseline measure
Measured: day 10
Decision to start antibiotic therapy after an initial opposite decision (after 48 hours)
Decision to start antibiotic therapy after an initial opposite decision (after 48 hours)
Measured: 30 days
Side effects of antibiotic treatment
Side effects of antibiotic treatment, such as gastro-intestinal complaints, allergic reactions
Measured: 30 days
Cumulative antibiotic consumption
The cumulative amount of antibiotic treatment consumed by the patient during follow-up
Measured: 30 days
Cumulative prednisolone consumption
The cumulative amount of prednisolone consumed by the patient during follow-up
Measured: 30 days
Length of hospitalization
Duration of time (in days) of the admission in hospital for the index exacerbation during follow-up
Measured: up to 30 days
Re-exacerbation
The presence of a new exacerbation, requiring treatment (prednisolone and/or antibiotic treatment) during follow-up
Measured: 30 days
EXACT respiratory questionnaire
PROM symptom score: EXACT - Respiratory symptoms scale
Measured: change between baseline and after 30 days
EXACT respiratory questionnaire
PROM symptom score: EXACT - Respiratory symptoms scale
Measured: baseline
EXACT respiratory questionnaire
PROM symptom score: EXACT - Respiratory symptoms scale
Measured: day 10
EXACT respiratory questionnaire
PROM symptom score: EXACT - Respiratory symptoms scale
Measured: day 30
CAT
COPD assessment test, quality of life questionnaire
Measured: baseline
CAT
COPD assessment test, quality of life questionnaire
Measured: day 10
CAT
COPD assessment test, quality of life questionnaire
Measured: day 30
CAT
COPD assessment test, quality of life questionnaire
Measured: change between baseline and day 30
EQ-5D-5L
quality of life questionnaire
Measured: baseline
EQ-5D-5L
quality of life questionnaire
Measured: day 10
EQ-5D-5L
quality of life questionnaire
Measured: day 30
EQ-5D-5L
quality of life questionnaire
Measured: change between baseline and day 30
iMCQ
Medical consumption questionnaire, measuring the total amount of medical consumption (admission, ER visits, outpatient visits) during follow-up
Measured: 30 days
Non-invasive ventilation after 72 hours of admission
Need for non-invasive ventilation after 72 hours of admission
Measured: 30 days
Time to complete resoluation of symptoms
- Time to complete resolution of symptoms according to daily symptom diaries evaluating the modified Anthonisen criteria
Measured: 30 days
Sputum Color Chart
Sputum colour chart, as previously published by Murray MP et al. Murray MP, Sputum colour: a useful clinical tool in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Aug;34(2):361-4. PMID 19648517.
Measured: On day 1 participants use a sputum color chart to report their current sputum color. This can be Mucoid, Mucopurulent (pale yellow/pale green), Purulent dark yellow, Purulent dark green
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start10 Aug 2021
- Primary completion6 Aug 2026
- Study completion6 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective randomized clinical multi-center study to evaluate procalcitonin-guided treatment regarding antibiotic use in patients who are admitted because of an acute COPD exacerbation. Patients who are admitted are randomly assigned to either procalcitonin-guided treatment (in which antibiotics are started when the procalcitonin concentration is above 0.25 ng/mL) or usual care in which the treating physician decides whether or not to start with antibiotic treatment. Patients will be stratified for study center.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 693 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Menno M. van der Eerden, Erasmus Medical Center
- Investigators
- Menno M van der Eerden, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854901
- Sponsor's protocol ID
- NL72662.078.20
- Other IDs
- NL9122
- Acronym
- PRECISION
- Status last verified
- Aug 2026
- First submitted
- 14 Feb 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin-guided Treatment Regarding Antibiotic Use for Acute COPD Exacerbations: a Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05854901
- Acronym / sponsor ID
- PRECISION / NL72662.078.20
- Conditions
- COPD Exacerbation, COPD, Acute Copd Exacerbation
- Keywords
- Procalcitonin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 693 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 6 Aug 2026 (actual)
- Study completion
- 6 Aug 2026 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a prevalent disease, worldwide, and in the Netherlands with approximately 600.000 patients. COPD is currently the 3rd leading cause of death worldwide and is also a leading cause of disability-adjusted life years. Given the contribution of exacerbations both to loss in quality of life and to health-care costs, it is of paramount importance to improve the current treatment of exacerbations.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective randomized clinical multi-center study to evaluate procalcitonin-guided treatment regarding antibiotic use in patients who are admitted because of an acute COPD exacerbation. Patients who are admitted are randomly assigned to either procalcitonin-guided treatment (in which antibiotics are started when the procalcitonin concentration is above 0.25 ng/mL) or usual care in which the treating physician decides whether or not to start with antibiotic treatment. Patients will be stratified for study center.
| Arm | Type | Receives |
|---|---|---|
| PCT-guided treatment | Experimental | Diagnostic Test: ProcalcitoninPatients randomized to this arm will only receive antibiotic treatment when the procalcitonin concentration is > 0.25ug/L. |
| Usual care | Active comparator | Other: Physician's decisionPatients randomized to this arm will receive antibiotic treatment based on the physician's decision. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProcalcitoninAlso: PCTblood test, measuring the concentration of PCT in ug/L | Diagnostic test | PCT-guided treatment |
| Physician's decisionThe physician's decided whether the patient will receive antibiotic treatment or not | Other | Usual care |
Primary outcome
Treatment failure
Time frame: 30 days
Treatment failure is defined as disease-related mortality, need for endotracheal intubation or vasopressors, renal failure (defined as Kidney Disease: Improving Global Outcomes (KDIGO) stage 3 - new renal replacement therapy, tripling of baseline creatinine, or serum creatinine > or = 350 umol/L), lung abcess/empyema, development of pneumonia or rehospitalization within 30 days after inclusion.
28 secondary outcomes
Incomplete resolution of the clinical signs and symptoms
Time frame: change between baseline and after 30 days
Incomplete resolution of the clinical signs and symptoms
Time frame: day 30
Modified Anthonisen criteria
Time frame: baseline
Modified Anthonisen criteria
Time frame: day 3
Modified Anthonisen criteria
Time frame: day 5
Modified Anthonisen criteria
Time frame: day 10
Decision to start antibiotic therapy after an initial opposite decision (after 48 hours)
Time frame: 30 days
Side effects of antibiotic treatment
Time frame: 30 days
Cumulative antibiotic consumption
Time frame: 30 days
Cumulative prednisolone consumption
Time frame: 30 days
Length of hospitalization
Time frame: up to 30 days
Re-exacerbation
Time frame: 30 days
EXACT respiratory questionnaire
Time frame: change between baseline and after 30 days
EXACT respiratory questionnaire
Time frame: baseline
EXACT respiratory questionnaire
Time frame: day 10
EXACT respiratory questionnaire
Time frame: day 30
CAT
Time frame: baseline
CAT
Time frame: day 10
CAT
Time frame: day 30
CAT
Time frame: change between baseline and day 30
EQ-5D-5L
Time frame: baseline
EQ-5D-5L
Time frame: day 10
EQ-5D-5L
Time frame: day 30
EQ-5D-5L
Time frame: change between baseline and day 30
iMCQ
Time frame: 30 days
Non-invasive ventilation after 72 hours of admission
Time frame: 30 days
Time to complete resoluation of symptoms
Time frame: 30 days
Sputum Color Chart
Time frame: On day 1 participants use a sputum color chart to report their current sputum color. This can be Mucoid, Mucopurulent (pale yellow/pale green), Purulent dark yellow, Purulent dark green
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Netherlands Trial Register registration included in ICTRPLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Menno M van der Eerden, MD, PhD principal investigator
Erasmus Medical Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procalcitonin and Physician's decision in people with COPD Exacerbation and COPD, run by Erasmus Medical Center at 11 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.