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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A02651-52 | Other Identifier | ID RCB |
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Incidence and morbi-mortality of Pneumocystis pneumonia (PCP) are increasing. Early and fast diagnosis and treatment improve PCP prognosis. Biological diagnosis is based on the detection of Pneumocystis jirovecii, mainly by PCR, in broncho-alveolar lavage (BAL) obtained from bronchial fibroscopy. However this invasive exam is not always possible in emergency in suspected patient and others non invasive (sputa) and/or non-targeted (bronchial aspiration) are sent to the laboratory (25% of cases, data from the Grenoble University Hospital). Diagnosis performances of these non invasive/non-targeted samples are not clearly established.
In this study, the investigators aimed to establish the diagnosis value of non-invasive and/or non-targeted respiratory samples (oral fluids, sputa and bronchial aspiration) for the PCP diagnosis, compared to the gold-standard (Pneumocystis PCR on BAL, beta-D-glucans testing on serum and radio-clinical records).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case : confirmed PCP diagnosis | Other | Sampling of non-invasive and/or non-targeted respiratory tract specimens |
|
| Control : non confirmed PCP diagnosis | Other | Sampling of non-invasive and/or non-targeted respiratory tract specimens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sampling of non-invasive and/or non-targeted respiratory tract specimens | Diagnostic Test | Sampling of oral fluids, sputa, bronchial aspiration in addition to BAL for the molecular diagnosis of PCP |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Sensitivity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard | 30 months |
| Specificity | Specificity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard | 30 months |
| Area Under the Curve (AUC) | AUCs of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard | 30 months |
| Estimation of the positive predictive value | Estimation of the predictive values of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard | 30 months |
| Estimation of the negative predictive value | Estimation of the negative predictive values of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time-saving (in hours) of PCP diagnosis on non-invasive and/or non-targeted respiratory samples compared to the PCP diagnosis on BAL, taking into account the time needed for bronchial fibroscopy | 30 months | |
| Optimal cut-off values for interpretation of Pneumocystis fungal load on non-invasive and/or non-targeted respiratory samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grenoble Alpes University Hospital | Grenoble | 38043 | France |
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| ID | Term |
|---|---|
| D011020 | Pneumonia, Pneumocystis |
| ID | Term |
|---|---|
| D008172 | Lung Diseases, Fungal |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| 30 months |
| Duration of anti-PCP treatment (days) | Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management | 30 months |
| Estimation of the number of days of presumptive anti-PCP treatment that would have been avoided based on a PCP diagnosis on non-invasive and/or non-targeted respiratory samples | Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management | 30 months |
| Estimation of the number of patients who would have received an earlier appropriate anti-PCP treatment based on a PCP diagnosis on non-invasive and/or non-targeted respiratory samples | Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management | 30 months |
| D016720 |
| Pneumocystis Infections |
| D012141 | Respiratory Tract Infections |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |