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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A00496-37 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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Mechanically ventilated patients are at risk of developing ventilator-associated pneumonia (VAP). Invasive pulmonary aspergillosis (IPA), the diagnosis of which motivates the implementation of specific treatments, is one of the causes of VAP. The hypothesis of the study is that the incidence of IPA is 12.4%. For each patient presenting with a suspicion of VAP and requiring a bronchoalveolar lavage (BAL), the diagnosis of API will be evaluated by biological examinations performed on blood and BAL. Medical and surgical history as well as clinical and biological data will be collected for 28 days or until discharge from the ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with suspected ventilator-associated pneumonia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological examinations performed on blood and BAL | Other | Direct examination and culture of BAL Galactomannan in serum and BAL Serum 1,3 beta D glucans Aspergillus PCR in BAL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of probable or proven IPA according to the Verweij criteria in patients with suspected VAP | On the 1 day of inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of IPA according to the Blot criteria | On the 1 day of inclusion | |
| Incidence of Aspergillus tracheobronchitis associated with IPA according to the Verweij criteria | On the 1 day of inclusion |
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Inclusion Criteria:
Adult patient (age ≥ 18 years),
On invasive ventilation for more than 48 hours,
Suspected VAP, defined by the appearance or worsening of a radiological pulmonary infiltrate, associated with 2 of the following clinical criteria:
Exclusion Criteria:
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Patients hospitalized in ICU
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| Name | Affiliation | Role |
|---|---|---|
| Saad NSEIR, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pôle de Réanimation Hôpital R. Salengro, CHU de Lille | Lille | France |
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| D055744 | Invasive Pulmonary Aspergillosis |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| Incidence of IPA according to the Verweij criteria in the subgroup without risk factors. | On the 1 day of inclusion |
| Mortality | at 28 days |
| Length of stay in intensive care unit | Until discharge from the ICU, an average 28 days |
| Duration of mechanical ventilation | Until discharge from the ICU, an average 28 days |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055732 | Pulmonary Aspergillosis |
| D001228 | Aspergillosis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D000072742 | Invasive Fungal Infections |
| D008172 | Lung Diseases, Fungal |