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| Name | Class |
|---|---|
| BioMérieux | INDUSTRY |
| Hospital Fribourg, Switzerland | UNKNOWN |
| Hôpital universitaire de Lausanne | UNKNOWN |
| Hospital of Neuchâtel |
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The objective of the study is to determine whether rapid multiplex PCR testing of respiratory samples can reduce exposure to broad-spectrum antibiotics in intensive care unit patients with suspected or confirmed ventilator-associated pneumonia, compared to standard diagnostic methods.
As secondary objectives, the investigators will study antibiotic management and overall antibiotic consumption, as well as escalation or de-escalation events. The investigators will study the potential clinical impact of using multiplex PCR to see if the length of stay in the intensive care unit is reduced, as well as the duration of mechanical ventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Care in the control group is based on international guidelines for the management of VAP and carried out in accordance with the local guidelines of each center. This includes respiratory samples with traditional cultures to identify pathogens associated with VAP. | |
| Intervention Group | Experimental | In the intervention arm, in addition to traditional cultures for identifying pathogens and their resistance, multiplex PCR will be performed on the patient's respiratory samples. Empirical antibiotic therapy will be directly adapted to the results of multiplex PCR according to the guidelines provided. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCR multiplex BioFire Pneumonia plus | Device | In the intervention arm, in addition to traditional cultures for identifying pathogens and their resistance, multiplex PCR will be performed on the patient's respiratory samples. Empirical antibiotic therapy will be directly adapted to the results of multiplex PCR according to the guidelines provided. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome is the broad-spectrum antibiotic-free hours at day 7 from inclusion | It is defined as the time, measured in hours, that the patient is alive and not treated with broad-spectrum antibiotics (≥ class 4 of ß-lactam according to Weiss et al.) within a period during from the date of randomization to day 7 or earlier if ICU discharge. | Seven days |
| Measure | Description | Time Frame |
|---|---|---|
| Median time (in hours) on broad-spectrum antibiotics during ICU stay. | 28 days | |
| Antibiotic free days defined as the number of days alive without antibiotics at Day 14 and Day 28. | 28 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christophe Le Terrier, MD | Contact | +41795532741 | christophe.leterrier@hug.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospitals of Geneva, Division of Intensive Care | Geneva | Canton of Geneva | 1205 | Switzerland |
Because we would like to publish the IPD before sharing.
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| UNKNOWN |
| Centre Hospitalier du Centre du Valais | OTHER |
| Hospital Lugano | UNKNOWN |
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|
| Time to antimicrobial switch (time to de-escalation or escalation) measured in hours. |
| Seven days |
| Rate of appropriate antimicrobial therapy at the following time points: inclusion, 24h after inclusion and 48h after inclusion. | I. Appropriate antimicrobial therapy is defined as follows:
II. Inappropriate antimicrobial therapy is defined as follows:
| 48 hours |
| ICU mortality and hospital mortality at Day 28 | 28 days |
| Ventilator free-days until Day 28 | 28 days |
| ICU length of stay | 28 days |
| Rate of adherence to antimicrobial guidelines at 48h. | Rate of patients treated following the antimicrobial guidelines provided in the study. | 48 hours |
| Dept. of Intensive Care Medicine, University hospital of Lausanne | Lausanne | Switzerland |
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| Division of Intensive care, Hospital of Lugano | Lugano | Switzerland |
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| Division of Intensive care, Hospital of Neuchâtel | Neuchâtel | Switzerland |
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| Division of Intensive care, University hospital of Sion | Sion | Switzerland |
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| 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 |
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