Sign in

NCT05854901Completed

PCT-guided Treatment Regarding Antibiotic Use for Acute COPD Exacerbations

Procalcitonin-guided Treatment Regarding Antibiotic Use for Acute COPD Exacerbations: a Prospective Randomised Controlled Trial

Source: ClinicalTrials.gov · Last updated 13 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
693 (actual)
First submitted
14 Feb 2023
Start date
10 Aug 2021
Primary completion date
6 Aug 2026
Lead sponsor
Erasmus Medical Center
Diseases
COPD
NCT number
NCT05854901

What you commit to

  • Study type: Interventional
  • Participants enrolled: 693
  • From 10 Aug 2021 to the primary completion date, 6 Aug 2026
  • 11 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Infection at another site and/or sepsis according to the SIRS criteria (with tachycardia and tachypnea not being caused by the exacerbation)
  • 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

Age

  • COPD before age 40

Other

  • Indication for ICU and or non-invasive ventilation \< 72h of admission
  • Pneumonia, radiologically confirmed
  • 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)

Who the study is looking for

  • 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

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Noordwest hospital group
Coordinator of this site? Confirm its status
AlkmaarNetherlandsUnknown status
OLVG
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status
Amphia Hospital
Coordinator of this site? Confirm its status
BredaNetherlandsUnknown status
Catharina hospital
Coordinator of this site? Confirm its status
EindhovenNetherlandsUnknown status
MST Enschede
Coordinator of this site? Confirm its status
EnschedeNetherlandsUnknown status
Groene Hart
Coordinator of this site? Confirm its status
GoudaNetherlandsUnknown status
Zuyderland hospital
Coordinator of this site? Confirm its status
HeerlenNetherlandsUnknown status
Bravis Hospital
Coordinator of this site? Confirm its status
RoosendaalNetherlandsUnknown status
Erasmus MC
Coordinator of this site? Confirm its status
RotterdamNetherlandsUnknown status
Franciscus Gasthuis & Vlietland
Coordinator of this site? Confirm its status
RotterdamNetherlandsUnknown status
Isala Klinieken
Coordinator of this site? Confirm its status
ZwolleNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.