An observational study in Community-acquired Pneumonia, Hospital-acquired Pneumonia and Ventilator Associated Pneumonia, sponsored by Avicenna Military Hospital. Completed at 1 site in Morocco. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-23.
Sponsored by Avicenna Military Hospital · Observational
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.
324 studies on the registry are indexed under Community-Acquired Pneumonia; 77 are open to participants now.
This study's enrollment of 210 is below the median of 650 across 111 observational studies indexed under Community-Acquired Pneumonia.
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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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Exclusion Criteria:
Critically ill patients with severe pneumonia under mechanical ventilation including ventilator-associated pneumonia, community-acquired or hospital-acquired pneumonia.
Diagnostic Test: Multiplex respiratory PCR
The BIOFIRE® FILMARRAY® Pneumonia plus Panel
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: 1. A true positive, when CMC and RM-PCR have identified the same microorganism (CMC+, PCR-RM +). 2. A false positive, when RM-PCR detected an organism but not CMC (CMC-, RM-PCR+) 3. A true negative, when no method detected any microorganism (CMC-, RM-PCR -) 4. A false negative, when CMC but not RM-PCR has detected an organism (CMC+, RM-PCR -). Sensitivity, specificity, and positive and negative predictive values for the respiratory multiplex PCR will be calculated using the precedent findings.
Time frame: 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. * Adequacy is defined as introducing an antibiotic to cover a microorganism that was not adequately treated before the results of RM-PCR. * Escalation is defined by a widening of the ATB spectrum to cover a pathogen not taken into account or the detection of resistance genes. * De-escalation is defined as the use of a narrower-spectrum anti-infective or the discontinuation of an ATB combination.
Time frame: through study completion, an average of 6 months
Plan to share: Yes — The datasets of the study will be available from the principal investigator on reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: until 5 years after study completion
Access criteria: Healthcare workers.
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Avicenna Military Hospital