Community-Acquired Pneumonia: lytA TArgeted real-time quantitative polymerase chaIN reaction for improved detection of pneumococci.
- Conditions
- Community-acquired pneumonialower respiratory tract infection1000401810024970
- Registration Number
- NL-OMON50405
- Lead Sponsor
- oordwest Ziekenhuisgroep
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 980
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 *C or <=36.0 *C (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, gender and time matched to an 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).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);
In general:
-Pneumonia in the last month or pneumococcal pneumonia (proven by usual
diagnostics) in the last three months;
-Not capable of understanding information needed to sign informed
consent;Patients:
-Was included in the present study group before;
-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);
-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 *C
-Chronic pulmonary disease: COPD, asthma, cystic fibrosis, bronchiectasis;
Control group 3 - Patients with stable COPD
-Temperature >38.0 *C;
-Stable disease;
-Recent exacerbation (<1 month) defined as increased respiratory symptoms with
need of antibiotic and/or corticosteroid therapy.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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>A. Primary studyparameters (patients)<br /><br>-Occurrence of qPCR proven pneumococcal pneumonia using the cut-off value in at<br /><br>least one of the specimens;<br /><br>-Occurrence of pneumococcal pneumonia proven by at least one of the routine<br /><br>microbiological tests.<br /><br><br /><br>B. Primary studyparameters (controls)<br /><br>Number of DNA copies of S. pneumoniae identified by lytA qPCR in samples of<br /><br>different locations in patients with a positive qPCR test:<br /><br>-Nasopharynx<br /><br>-Oropharynx<br /><br>-Saliva<br /><br>-Sputum </p><br>
- Secondary Outcome Measures
Name Time Method <p>A. Secondary study parameters (patients)<br /><br>-Occurrence of positive lytA qPCR in the different samples: oropharynx,<br /><br>nasopharynx, saliva and sputum;<br /><br>-Occurrence of S. pneumoniae identified in the different samples by routine<br /><br>microbiological tests;<br /><br>-Number of DNA copies of S. pneumoniae in all lytA qPCR positive patients;<br /><br>-Ct-values in all lytA qPCR positive study subjects;<br /><br>-CURB-65 scores (or other pneumonia severity scores);<br /><br>-CRP levels;<br /><br>-PCT levels.<br /><br><br /><br>B. Secondary study parameters (controls)<br /><br>-Occurrence of S. pneumoniae identified with lytA qPCR in at least one of the<br /><br>specimens;<br /><br>-Occurrence of S. pneumoniae identified in at least one of the specimens with<br /><br>cultures (culture of oropharyngeal or nasopharyngeal swab or saliva);<br /><br>-Ct-values in all lytA qPCR positive study subjects.</p><br>