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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A00149-46 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| Curetis GmbH | INDUSTRY |
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VAPERO is a randomized, unblinded, controlled study to measure the impact of a strategy based on the Unyvero® multiplex PCR test on the adjustment of antimicrobial therapy in patients suspected with ventilator-associated or hospital-acquired pneumonia (VAP/HAP) requiring mechanical ventilation. The gold-standard microbiological diagnostic method for pneumonia in the ICU is still culture-based identification and antimicrobial susceptibility testing (AST) despite being more than a hundred years old, with results turnaround time spanning over several days, exposing patients to potentially inappropriate broad-spectrum antimicrobial therapy. The investigators aim to measure the impact of the Unyvero® testing strategy to improve the percentage of patients with VAP or HAP receiving early targeted antimicrobial therapy compared to standard care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FilmArray® Pneumonia panel plus strategy | Experimental | patients benefiting from the new strategy based on the system Unyvero ® |
|
| Standard care | Sham Comparator | patients benefiting from usual standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FilmArray® Pneumonia panel plus | Other | Early adjustment of antimicrobial therapy according to the results of the Unyvero® testing for patients suspected with VAP or HAP requiring MV. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with targeted antibiotics regimen 24 hours after starting antimicrobial therapy in the experimental group compared to control group | 24 hours after the initiation of empiric antimicrobial therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients receiving appropriate antimicrobial therapy 24 hours after antibiotics initiation | 24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start | |
| Amount of days alive and free from mechanical ventilation at day 28 after antibiotics initiation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saad Nseir, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Lille | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33395094 | Result | Kerneis S, Visseaux B, Armand-Lefevre L, Timsit JF. Molecular diagnostic methods for pneumonia: how can they be applied in practice? Curr Opin Infect Dis. 2021 Apr 1;34(2):118-125. doi: 10.1097/QCO.0000000000000713. |
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| Standard care | Other | Standard care, with broad-spectrum antimicrobial therapy unchanged until reception of traditional microbiology results |
|
| 24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start |
| Length of stay in Intensive Care Unit | 24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start |
| Number of Patient Deaths | number of patient deaths after antibiotics start | at 28 days after antibiotics start |
| number of patient deaths in ICU | 24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| D018410 | Pneumonia, Bacterial |
| D000077299 | Healthcare-Associated Pneumonia |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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