An observational study in Pneumonia, Pneumococcal and Community-acquired Pneumonia, sponsored by Medical Center Alkmaar. Completed at 2 sites in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-08.
Sponsored by Medical Center Alkmaar · Observational
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.
44 studies on the registry are indexed under Pneumonia, Pneumococcal; 2 are open to participants now.
Browse Pneumonia, Pneumococcal studies →Medical Center Alkmaar is the lead sponsor of 20 studies on the registry; none are open to participants now.
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Patient group: Adult patients ≥18 years with diagnosis of CAP at the emergency department (ED).
Control groups (without CAP):
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients:
Working diagnosis of CAP at the ED with the presence of at least two of the following criteria:
Control group 1 - Related controls
Control group 2 - Unrelated healthy individuals
Control group 3 - Patients with stable
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR)
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)
Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR)
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)
Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR)
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)
Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR)
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)
Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR)
LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available)
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.
Time frame: 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.
Time frame: 1 day, day of inclusion
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.
Time frame: 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.
Time frame: 30 days
CURB-65 scores
CURB-65 scores will be determined in CAP patients at moment of inclusion.
Time frame: 1 day, day of inclusion
Procalcitonin
Procalcitonin levels will be determined in CAP patients at moment of inclusion.
Time frame: 1 day, day of inclusion
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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