Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT03315403
Eligibility Criteria:
Inclusion Criteria:
Patients:
* Age 18 years or above;
* Presentation at the emergency department (ED);
* Working diagnosis of CAP at the ED with the presence of at least two of the following criteria:
1. New or worsened coughing;
2. Production of purulent sputum or change in sputum colour;
3. Temperature \>38.0 ⁰C or ≤36.0 ⁰C (tympanic);
4. Auscultatory findings consistent with pneumonia, including rales, evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, rales, or egophony), or both;
5. White blood cell count of \>10x10\^9 cells/L or \<4x10\^9 cells/L or \>15% bands;
6. C-reactive protein level ≥30mg/L;
7. Dyspnea, tachypnea, (\>20 breaths per minute), or hypoxemia (arterial pO2 \<60mmHg or peripheral O2 saturation \<90%).
* New consolidation(s) on the chest radiograph or computed tomography (CT);
* No other explanation for the signs and symptoms;
Control group 1 - Related controls
* Being aged 18 years or above;
* Close relative of the patient: relative defined as living in the same house as the CAP patient or daily contact;
* Is at the hospital at the moment of inclusion of the CAP patient or is willing to come for testing within 7 days;
Control group 2 - Unrelated healthy individuals
* Being aged 18 years or above;
* Subject with a preoperative appointment with the anaesthiologist for a planned surgical procedure;
* Age matched to a included CAP patient (+-10 years);
* Time matched to a included CAP patient (up to 14 days after inclusion of the CAP patient);
* Gender matched to a included CAP patient.
Control group 3 - Patients with stable COPD
* Being aged 18 years or above;
* Diagnosis of COPD confirmed with spirometry (GOLD criteria 2017)(76);
* Stable disease.
Control group 4 - Patients with exacerbation of COPD
* Being aged 18 years or above;
* Diagnosis of COPD confirmed with spirometry (GOLD criteria 2017)(76);
* Diagnosis of exacerbation of COPD: defined as an acute event characterised by a worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication (76).
* Presentation at emergency department with the suspicion of an exacerbation.
Exclusion Criteria:
In general:
* Recent pneumonia (\< 1 month) or pneumonia in last 3 months with known pneumococcal aetiology with one of current diagnostics;
* Was included in the study group before;
* Not capable of understanding information needed to sign informed consent.
Patients:
* Aspiration pneumonia;
* Hospitalisation for two or more days in the last 14 days;
* History of cystic fibrosis.
For all control groups:
* Fits inclusion criteria for patient group;
* Present or recent hospitalisation (14 days);
* Fits inclusion criteria for patient group;
* Use of antibiotics in the last 14 days, including maintenance antibiotic therapy.
Control group 1 and 2 - Related healthy controls and unrelated healthy individuals
* Active infectious respiratory complaints defined as defined as two or more respiratory symptoms (cough, nasal congestion, runny nose, sore throat or sneezes);
* Temperature \>38.0 ⁰C;
* Fits inclusion criteria for control group 3 or 4;
* Chronic pulmonary disease: COPD, asthma, cystic fibrosis, bronchiectasis.
Control group 3 - Patients with stable COPD
* Temperature \>38.0 ⁰C;
* Stable disease;
* Fits inclusion criteria for control group 4;
* Recent exacerbation (\<1 month) defined as increased respiratory symptoms with need of antibiotic and/or corticosteroid therapy;
* History of cystic fibrosis.
Control group 4 - Patients with exacerbation of COPD
* Current pneumonia;
* Recent exacerbation (\<1 month) defined as increased respiratory symptoms with need of antibiotic and/or corticosteroid therapy;
* Fits inclusion criteria for control group 3;
* History of cystic fibrosis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03315403
Study Brief:
Protocol Section:
NCT03315403