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Blood test may curb antibiotic overuse in COPD attacks

NCT ID NCT05854901

Disease control Sponsor: Erasmus Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial tests whether using a blood test that measures procalcitonin—a marker of bacterial infection—can safely guide decisions about antibiotics in people hospitalized for a COPD flare-up. Participants are randomly assigned to either usual care or procalcitonin-guided treatment, where antibiotics are given only if the test suggests a bacterial cause. The goal is to see if this approach is as safe as standard care, with the potential to reduce unnecessary antibiotic use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Procalcitonin blood test to guide antibiotic decisions
What this could lead to
If effective, this approach could reduce unnecessary antibiotic use in COPD flare-ups, lowering side effects and antibiotic resistance while maintaining patient safety.
What could go wrong
The trial is early and non-inferiority design means it aims to show no worse outcomes, but there is a risk that skipping antibiotics based on the test could lead to more treatment failures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

693 people

The number who actually took part.

Started

Aug 2021

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute COPD exacerbation COPD COPD exacerbation

Contacts and locations

Locations

  • Amphia hospital

    Breda, North Brabant, 4818CK, Netherlands

  • Bravis hospital

    Roosendaal, North Brabant, 4708AE, Netherlands

  • Catharina hospital

    Eindhoven, North Brabant, 5623 EJ, Netherlands

  • Erasmus MC

    Rotterdam, South Holland, 3015GD, Netherlands

  • Franciscus Gasthuis & Vlietland

    Rotterdam, South Holland, 3045PM, Netherlands

  • Groene Hart

    Gouda, South Holland, 2803HH, Netherlands

  • Isala klinieken

    Zwolle, Overijssel, 8025 AB, Netherlands

  • MST Enschede

    Enschede, Overijssel, 7500KA, Netherlands

  • Noordwest hospital group

    Alkmaar, North Holland, 1800AM, Netherlands

  • OLVG

    Amsterdam, North Holland, 1091AC, Netherlands

  • Zuyderland hospital

    Heerlen, Limburg, 6419PC, Netherlands

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