PCT-guided Treatment Regarding Antibiotic Use for Acute COPD Exacerbations

Last updated: May 9, 2023
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Physician's decision

Procalcitonin

Clinical Study ID

NCT05854901
NL72662.078.20
NL9122
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • COPD, according to GOLD 2018 definition
  • Indication for hospitalization because of acute severe exacerbation of COPD, asdefined by GOLD 2018 and modified Anthonisen criteria
  • Presence of at least 2 major symptoms of the modified Anthonisen criteria (acutedeterioration in sputum volume, sputum purulence and dyspnea) or the presence of 1major 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

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 (withtachycardia 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 anadolescent) will NOT be excluded/are allowed to participate.
  • Patients with Asthma/COPD overlap syndrome (with current asthma AND COPD) willNOT 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 Design

Total Participants: 693
Treatment Group(s): 2
Primary Treatment: Physician's decision
Phase:
Study Start date:
August 10, 2021
Estimated Completion Date:
February 28, 2025

Study 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.

Connect with a study center

  • Zuyderland hospital

    Heerlen, Limburg 6419PC
    Netherlands

    Site Not Available

  • Amphia hospital

    Breda, Noord-Brabant 4818CK
    Netherlands

    Active - Recruiting

  • Catharina hospital

    Eindhoven, Noord-Brabant 5623 EJ
    Netherlands

    Site Not Available

  • Bravis hospital

    Roosendaal, Noord-Brabant 4708AE
    Netherlands

    Site Not Available

  • Noordwest hospital group

    Alkmaar, Noord-Holland 1800AM
    Netherlands

    Active - Recruiting

  • OLVG

    Amsterdam, Noord-Holland 1091AC
    Netherlands

    Active - Recruiting

  • MST Enschede

    Enschede, Overijssel 7500KA
    Netherlands

    Site Not Available

  • Isala klinieken

    Zwolle, Overijssel 8025 AB
    Netherlands

    Active - Recruiting

  • Groene Hart

    Gouda, Zuid-Holland 2803HH
    Netherlands

    Active - Recruiting

  • Erasmus MC

    Rotterdam, Zuid-Holland 3015GD
    Netherlands

    Site Not Available

  • Franciscus Gasthuis & Vlietland

    Rotterdam, Zuid-Holland 3045PM
    Netherlands

    Active - Recruiting

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