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The objective of this study is to assess the diagnostic performance of multiplex respiratory PCR (PCR-RM) compared to standard microbiological tests and its potential impact on the early adaptation of antibiotic treatment in intensive care patients with severe pneumonia.
This is a prospective, observational, multicenter ICU study. Adult patients with severe pneumonia requiring invasive mechanical ventilation will be included. Severe pneumonia consists of 3 categories of pneumonia: community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), and ventilator-acquired pneumonia (VAP). The microbiological testing will be performed before antibiotic initiation on tracheobronchial aspirations, protected distal sampling, or mini-bronchoalveolar lavage as part of routine care. No additional samples will becollected for this study. Respiratory samples will be simultaneously tested by conventional microbiological techniques and multiplex respiratory PCR [PCR-RM] (BIOFIRE® FILMARRAY® Pneumonia Panel Plus). Classical microbiological culture (CMC) will be considered the gold standard for microbiological pneumonia diagnosis. The agreement between the results of the Pneumonia Plus® panel and the results of conventional microbial culture (CMC) will be assessed.
An empiric antibiotic therapy will be prescribed according to the local ecology and the protocols of each ICU unit. Two senior experts in each participating center will have to approve the antibiotic prescription. The antibiotic therapy could be modified after the reception of the Mutilpex PCR results by the two senior experts. After the reception of the results of the classic microbiological culture, the previous antibiotic changes will be judged as appropriate or inappropriate by a multidisciplinary team including intensivists, infectious disease specialists, and microbiologists. Appropriate changes include adequacy, de-escalation, and optimization of antibiotic therapy, and inappropriate changes include inadequacy, escalation, and de-optimization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICU patients with severe pneumonia | Critically ill patients with severe pneumonia under mechanical ventilation including ventilator-associated pneumonia, community-acquired or hospital-acquired pneumonia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiplex respiratory PCR | Diagnostic Test | The BIOFIRE® FILMARRAY® Pneumonia plus Panel |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of diagnostic concordance between Classical microbiological cultures and the respiratory multiplex PCR (RM-PCR) and conventional microbiological cultures (CMC) to identify pathogens responsible for severe pneumonia in critically ill patients. | Classical microbiological cultures (CMC) will serve as the gold standard for the comparison between techniques, considering a test result:
Sensitivity, specificity, and positive and negative predictive values for the respiratory multiplex PCR will be calculated using the precedent findings. | through study completion, an average of 6 months |
| The impact of the respiratory multiplex PCR (RM-PCR) on the appropriateness of empirical antimicrobial therapy. | The proportion of patients for whom the respiratory multiplex PCR (RM-PCR) induces an appropriate change of antibiotic therapy. Appropriate changes include adequacy, de-escalation, and escalation of antibiotic treatment.
| through study completion, an average of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
- Non-invasive mechanical ventilation.
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Critically ill patients with ventilator-associated pneumonia (VAP), community-acquired pneumonia (CAP), or hospital-acquired pneumonia (HAP). For CAP and HAP, only patients under invasive mechanical ventilation will be included.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avicenna Military Hospital | Marrakesh | Marrakesh Tensift El Haouz | 40000 | Morocco |
The datasets of the study will be available from the principal investigator on reasonable request.
until 5 years after study completion
Healthcare workers.
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| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| D000077299 | Healthcare-Associated Pneumonia |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| D012140 |
| Respiratory Tract Diseases |
| D003428 | Cross Infection |
| D008171 | Lung Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |