PCT-guided Treatment Regarding Antibiotic Use for Acute COPD Exacerbations
PRECISION
Procalcitonin-guided Treatment Regarding Antibiotic Use for Acute COPD Exacerbations: a Prospective Randomised Controlled Trial
2 other identifiers
interventional
693
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2021
CompletedFirst Submitted
Initial submission to the registry
February 14, 2023
CompletedFirst Posted
Study publicly available on registry
May 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedMay 11, 2023
May 1, 2023
3.5 years
February 14, 2023
May 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30 days
Secondary Outcomes (27)
Incomplete resolution of the clinical signs and symptoms
change between baseline and after 30 days
Incomplete resolution of the clinical signs and symptoms
day 30
Modified Anthonisen criteria
baseline
Modified Anthonisen criteria
day 3
Modified Anthonisen criteria
day 5
- +22 more secondary outcomes
Other Outcomes (1)
Cost-effective analysis
30 days
Study Arms (2)
PCT-guided treatment
EXPERIMENTALPatients randomized to this arm will only receive antibiotic treatment when the procalcitonin concentration is \> 0.25ug/L.
Usual care
ACTIVE COMPARATORPatients randomized to this arm will receive antibiotic treatment based on the physician's decision.
Interventions
blood test, measuring the concentration of PCT in ug/L
The physician's decided whether the patient will receive antibiotic treatment or not
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Zuyderland hospital
Heerlen, Limburg, 6419PC, Netherlands
Amphia hospital
Breda, North Brabant, 4818CK, Netherlands
Catharina hospital
Eindhoven, North Brabant, 5623 EJ, Netherlands
Bravis hospital
Roosendaal, North Brabant, 4708AE, Netherlands
Noordwest hospital group
Alkmaar, North Holland, 1800AM, Netherlands
OLVG
Amsterdam, North Holland, 1091AC, Netherlands
MST Enschede
Enschede, Overijssel, 7500KA, Netherlands
Isala klinieken
Zwolle, Overijssel, 8025 AB, Netherlands
Groene Hart
Gouda, South Holland, 2803HH, Netherlands
Erasmus MC
Rotterdam, South Holland, 3015GD, Netherlands
Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, 3045PM, Netherlands
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Menno M van der Eerden, MD, PhD
Erasmus Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator and Pulmonologist
Study Record Dates
First Submitted
February 14, 2023
First Posted
May 11, 2023
Study Start
August 10, 2021
Primary Completion
February 1, 2025
Study Completion
February 1, 2025
Last Updated
May 11, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share