PCT-guided Treatment Regarding Antibiotic Use for Acute COPD Exacerbations (PRECISION)

August 11, 2026 updated by: Menno M. van der Eerden, Erasmus Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
693

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • Limburg
      • Heerlen, Limburg, Netherlands, 6419PC
        • Zuyderland hospital
    • North Brabant
      • Breda, North Brabant, Netherlands, 4818CK
        • Amphia Hospital
      • Eindhoven, North Brabant, Netherlands, 5623 EJ
        • Catharina Hospital
      • Roosendaal, North Brabant, Netherlands, 4708AE
        • Bravis hospital
    • North Holland
      • Alkmaar, North Holland, Netherlands, 1800AM
        • Noordwest hospital group
      • Amsterdam, North Holland, Netherlands, 1091AC
        • OLVG
    • Overijssel
      • Enschede, Overijssel, Netherlands, 7500KA
        • MST Enschede
      • Zwolle, Overijssel, Netherlands, 8025 AB
        • Isala Klinieken
    • South Holland
      • Gouda, South Holland, Netherlands, 2803HH
        • Groene Hart
      • Rotterdam, South Holland, Netherlands, 3015GD
        • Erasmus MC
      • Rotterdam, South Holland, Netherlands, 3045PM
        • Franciscus Gasthuis & Vlietland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

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.

    • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PCT-guided treatment
Patients randomized to this arm will only receive antibiotic treatment when the procalcitonin concentration is > 0.25ug/L.
Diagnostic test: Procalcitonin
blood test, measuring the concentration of PCT in ug/L
Other Names:
  • PCT
Active Comparator: Usual care
Patients randomized to this arm will receive antibiotic treatment based on the physician's decision.
Other: Physician's decision
The physician's decided whether the patient will receive antibiotic treatment or not

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 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
change between baseline and after 30 days
Incomplete resolution of the clinical signs and symptoms
Time Frame: day 30
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
day 30
Modified Anthonisen criteria
Time Frame: baseline
Patients fill in the modified Anthonisen criteria card on day 1 as a baseline measure
baseline
Modified Anthonisen criteria
Time Frame: day 3
Patients fill in the modified Anthonisen criteria card on day 3
day 3
Modified Anthonisen criteria
Time Frame: day 5
Patients fill in the modified Anthonisen criteria card on day 1 as a baseline measure
day 5
Modified Anthonisen criteria
Time Frame: day 10
Patients fill in the modified Anthonisen criteria card on day 1 as a baseline measure
day 10
Decision to start antibiotic therapy after an initial opposite decision (after 48 hours)
Time Frame: 30 days
Decision to start antibiotic therapy after an initial opposite decision (after 48 hours)
30 days
Side effects of antibiotic treatment
Time Frame: 30 days
Side effects of antibiotic treatment, such as gastro-intestinal complaints, allergic reactions
30 days
Cumulative antibiotic consumption
Time Frame: 30 days
The cumulative amount of antibiotic treatment consumed by the patient during follow-up
30 days
Cumulative prednisolone consumption
Time Frame: 30 days
The cumulative amount of prednisolone consumed by the patient during follow-up
30 days
Length of hospitalization
Time Frame: up to 30 days
Duration of time (in days) of the admission in hospital for the index exacerbation during follow-up
up to 30 days
Re-exacerbation
Time Frame: 30 days
The presence of a new exacerbation, requiring treatment (prednisolone and/or antibiotic treatment) during follow-up
30 days
EXACT respiratory questionnaire
Time Frame: change between baseline and after 30 days
PROM symptom score: EXACT - Respiratory symptoms scale
change between baseline and after 30 days
EXACT respiratory questionnaire
Time Frame: baseline
PROM symptom score: EXACT - Respiratory symptoms scale
baseline
EXACT respiratory questionnaire
Time Frame: day 10
PROM symptom score: EXACT - Respiratory symptoms scale
day 10
EXACT respiratory questionnaire
Time Frame: day 30
PROM symptom score: EXACT - Respiratory symptoms scale
day 30
CAT
Time Frame: baseline
COPD assessment test, quality of life questionnaire
baseline
CAT
Time Frame: day 10
COPD assessment test, quality of life questionnaire
day 10
CAT
Time Frame: day 30
COPD assessment test, quality of life questionnaire
day 30
CAT
Time Frame: change between baseline and day 30
COPD assessment test, quality of life questionnaire
change between baseline and day 30
EQ-5D-5L
Time Frame: baseline
quality of life questionnaire
baseline
EQ-5D-5L
Time Frame: day 10
quality of life questionnaire
day 10
EQ-5D-5L
Time Frame: day 30
quality of life questionnaire
day 30
EQ-5D-5L
Time Frame: change between baseline and day 30
quality of life questionnaire
change between baseline and day 30
iMCQ
Time Frame: 30 days
Medical consumption questionnaire, measuring the total amount of medical consumption (admission, ER visits, outpatient visits) during follow-up
30 days
Non-invasive ventilation after 72 hours of admission
Time Frame: 30 days
Need for non-invasive ventilation after 72 hours of admission
30 days
Time to complete resoluation of symptoms
Time Frame: 30 days
· Time to complete resolution of symptoms according to daily symptom diaries evaluating the modified Anthonisen criteria
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
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.
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cost-effective analysis
Time Frame: 30 days
Alongside the clinical trial, an economic evaluation will be performed conform the guidelines of the Health Care Institute Netherlands (17). This evaluation will be conducted from a societal and payer's perspective. When adopting the societal perspective, costs will include 30-day inpatient and outpatient (emergency room, specialist visits) hospital costs, primary care costs (visits to GP and nurse practitioner), medication costs, ambulance costs, productivity costs, informal care costs and travel costs.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Menno M van der Eerden, MD, PhD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 6, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 6, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL72662.078.20
  • NL9122 (Registry Identifier: Netherlands Trial Register)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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