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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB | Other Identifier | 2021-A03122-39 |
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Patients on mechanical ventilation (MV) following SARS-CoV-2 pneumonia frequently develop ventilator-associated pneumonia (VAP). The incidence of MVAP during SARS-CoV-2 infections ranges from 50 to nearly 90%. In addition, up to 80% of recurrences of VAP (a new episode, most often attributable to the same bacteria) have been described, reflecting the failure of the initial antibiotic therapy. This incidence is much higher than that described for other etiologies of acute respiratory distress syndrome (ARDS). The investigators hypothesize that during VAP, there is an alteration of the diffusion of intravenous antibiotics in the lung parenchyma in COVID-19 patients in relation to several factors characteristic of SARS-CoV-2 infection. This altered diffusion may explain the high number of recurrences of MVAP compared to non-COVID-19 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients positive to SARS-CoV 2 | Experimental | Patients admitted to the ICU and placed on VM following SARS-CoV-2 pneumonia |
|
| Patients negative to SARS-CoV 2 | Sham Comparator | Patients admitted to the ICU and placed on VM outside of SARS-CoV-2 pneumonia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sample and bronchoalveolar lavage | Other | These patients are put on VM as part of their care and present a suspicion of a 1st episode of PAVM for which a microbiological sample is taken and a probabilistic antibiotic therapy is started with the PIP-TAZ association (D0). A plasma PIP-TAZ assay will be performed 48 hours after the start of antibiotic therapy with PIP-TAZ. Blood urea will be measured and a mini-LBA (performed with a Combicatheter®) will be performed to measure PIP-TAZ and urea in the ELF. On day 7 of the antibiotic therapy (last day of the planned antibiotic therapy), the same samples are taken and the same analyses are performed + bacteriology on the mini BAL. For patients for whom antibiotic therapy has been interrupted because of sterile samples, the samples taken at D7 will not be taken. The clinical outcome of the patient will then be recorded until D60. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the pulmonary diffusion of piperacillin | Dosage in the epithelial lining fluid | 48 hours following antibiotics administration |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary diffusion of tazobactam | Dosage in the epithelial lining fluid | 48 hours following antibiotics administration |
| Concentrations of piperacillin in effective pulmonary and plasma targets |
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Inclusion Criteria:
1. Patient over 18 years of age 2. Patient has given consent or consent obtained from the trusted person if the patient is not capable of consenting, after informed consent.
3. Patient with ARDS 4. Patient requiring MV for ARDS (as defined by Berlin (15)), regardless of etiology (COVID-19 or other cause of ARDS) 5. Patient with suspected 1st episode of ARDS for which microbiological sampling is performed (bronchial aspiration, protected distal sampling (PDS), bronchoalveolar lavage (BAL)) 6. Patients who have received probabilistic antibiotic therapy within 24 hours of the microbiological sample, including piperacillin-tazobactam (PIP-TAZ) administered according to current recommendations.
7. Patient who is a beneficiary of or affiliated to a social security system
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François Cremieux | AP-HM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service Médecine Intensive Réanimation | Marseille | 13015 | France |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D018893 | Bronchoalveolar Lavage |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
Piperacillin concentrations in Epithelial Lining Fluid
| 48 hours following antibiotics administration |
| Concentrations of piperacillin in effective pulmonary and plasma targets | Piperacillin concentrations in plasma | 7 days following antibiotics administration |
| Concentrations of tazobactam in effective pulmonary and plasma targets | Tazobactam concentrations in Epithelial Lining Fluid | 7 days following antibiotics administration |
| Concentrations of tazobactam in effective pulmonary and plasma targets | Tazobactam concentrations in Epitehlial Lining Fluid and plasma separately at H48 and 7 days after initiation of antibiotic therapy | 48 hours following antibiotics administration |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D007507 | Therapeutic Irrigation |