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The purpose of this study is to evaluate the added diagnostic value of a quantitative polymerase chain reaction targeting the lytA gene in detecting pneumococci in patients with community-acquired pneumonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with CAP | Patients with a diagnosis of radiographically-confirmed CAP at the emergency department will undergo the usual diagnostics. For the study an extra nasopharynx sample, saliva sample and blood sample will be collected. A questionnaire will be filled in. LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available) |
| |
| Related controls | Of related controls a nasopharynx sample, oropharynx sample and saliva sample will be collected. A questionnaire will be filled in. LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva) |
| |
| Unrelated controls | Of unrelated controls a nasopharynx sample, oropharynx sample and saliva sample will be collected. A questionnaire will be filled in. LytA PCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva) |
| |
| Patients with stable COPD | Of stable COPD patients a nasopharynx sample, oropharynx sample and saliva sample will be collected. And if available also a sputum sample. A questionnaire will be filled in. LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LytA targeted quantitative polymerase chain reaction (qPCR) | Diagnostic Test | LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available) |
| Measure | Description | Time Frame |
|---|---|---|
| qPCR diagnosed pneumococcal pneumonia | Occurrence of qPCR proven pneumococcal pneumonia (CAP with S. pneumoniae detected by qPCR in at least one of the samples with a positive lytA qPCR and a DNA copy number above the determined cut-off value) using the cut-off value in at least one of the specimens at inclusion. The cut-off value will be determined in this study, see secondary objective. | 1 day, day of inclusion |
| Pneumococcal pneumonia with usual tests | Occurrence of pneumococcal pneumonia proven by at least one of the routine microbiological tests (urine antigen test, blood culture and/or sputum culture). The difference between outcome measure 1 and 2 is the added diagnostic value. | 1 day, day of inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of DNA copies of S. pneumoniae in all lytA qPCR positive study subjects | The number of DNA copies of every study subject with a positive qPCR will be determined. The optimal cut-off value will be determined to distinguish between colonisation and infection by comparing the number of DNA copies of controls with a positive lytA PCR and patients with a pneumococcal pneumonia proven by routine microbiological tests. This cut-off value will be used for outcome measure 1 to determine the amount of patients with an qPCR proven pneumococcal pneumonia. |
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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:
New consolidation(s) on the chest radiograph or computed tomography (CT);
No other explanation for the signs and symptoms;
Control group 1 - Related controls
Control group 2 - Unrelated healthy individuals
Control group 3 - Patients with stable COPD
Control group 4 - Patients with exacerbation of COPD
Exclusion Criteria:
In general:
Patients:
For all control groups:
Control group 1 and 2 - Related healthy controls and unrelated healthy individuals
Control group 3 - Patients with stable COPD
Control group 4 - Patients with exacerbation of COPD
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Patient group: Adult patients ≥18 years with diagnosis of CAP at the emergency department (ED).
Control groups (without CAP):
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| Name | Affiliation | Role |
|---|---|---|
| Wim Boersma, MD. PhD. | Noordwest Ziekenhuisgroep | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaarne Gasthuis | Haarlem | North Holland | Netherlands | |||
| Noordwest Ziekenhuisgroep |
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| ID | Term |
|---|---|
| D011018 | Pneumonia, Pneumococcal |
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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Collection of nasopharynx, oropharynx, saliva, sputum and blood.
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| Patients with exacerbation of COPD | Of patients with a diagnosis of an exacerbation of COPD at the emergency department a nasopharynx sample, oropharynx sample and saliva sample will be collected apart from the usual diagnostics. If available also a sputum sample will be collected. A questionnaire will be filled in. LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available) |
|
| 1 day, day of inclusion |
| Occurrence of positive lytA qPCR at 30 days after inclusion in CAP patients | Occurrence of positive lytA qPCR at 30 days after inclusion in CAP patients in the different samples: oropharynx, nasopharynx, saliva and sputum. | 30 days |
| CURB-65 scores | CURB-65 scores will be determined in CAP patients at moment of inclusion. | 1 day, day of inclusion |
| Procalcitonin | Procalcitonin levels will be determined in CAP patients at moment of inclusion. | 1 day, day of inclusion |
| Alkmaar |
| Netherlands |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018410 | Pneumonia, Bacterial |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017714 | Community-Acquired Infections |