To determine the true prevalence of pneumonia in exacerbating COPD patients by low-dose CT
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the true prevalence of pneumonia in exacerbating COPD patients as
analysed by low dose-CT
Secondary outcome
- To determine clinical and/or biochemical predictors (PCT) for pneumonia in
COPD patients proven by low dose-CT;
- To describe additional pulmonary pathology evidenced by low dose-CT;
- Phenotype COPD exacerbations based on outcomes of low dose-CT (standardized
assessment).
Background summary
COPD is a burdensome chronic disease, which has a huge impact on patient*s
life. Many experience exacerbations, which are acute deteriorations of the
disease and reduce the quality of life, speed the disease progression and
increase the risk of death. Despite the intense research efforts, it remains
difficult to differentiate exacerbations from pneumonia*s in patients with
COPD. A more comprehensive tool is required, to diagnose and phenotype
exacerbations and guide treatment, in order to avoid *mistreatment* as much as
possible. Low-dose CT has been shown to be more sensitive in detecting
pneumonia in COPD patients compared to standard chest x-ray. Procalcitonin is a
serum biomarker that has been succesfully used to shorten antibiotic treatment
in COPD exacerbations and is currently being evaluated as a prognostic marker
for bacterial infections.
Study objective
To determine the true prevalence of pneumonia in exacerbating COPD patients by
low-dose CT
Study design
A prospective single-centre cohort study.
Study burden and risks
The burden of the research will be very low, as procedures take place during
hospital admission. Additionally, a low dose-CT will be performed, as well as
two extra bloodsamples (combined with a blood sample for treatment purposes).
Both procedures won't take a lot of extra time, and are daily used in clinical
practice. Moreover, three questionnaires will be taken. Estimated risk is very
low.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
• Adults, either sex, older than 40 years of age;
• Smoking history of 10 Pack Years or more;
• Diagnosis of COPD stages I-IV, class A-D, as defined by the Global initiative for chronic Obstructive Lung Disease (GOLD);
• Doctor*s diagnosis of AECOPD (clinical presentation of a patient complaining of an acute change of symptoms that is beyond normal day-to-day variation - baseline dyspnoea, cough and/or sputum production);
• Patients must sign and date an informed consent prior to inclusion in the study.
Exclusion criteria
• Progressively fatal disease, or life expectancy <=6 months;
• Women who are breast feeding or are pregnant;
• Patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study;
• Patients participating in an intervention study which influences outcomes;
• Un-ability to lie flat for the performance of CT-scan.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL49554.068.14 |
| Other | Onderzoek wordt geregistreerd zodra goedkeuring is ontvangen (op www.trialregister.nl) |
| OMON | NL-OMON26796 |