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Abstract Background: Critically ill patients with pneumonia pose a significant clinical challenge due to the difficulty of rapid and accurate diagnosis. Conventional sputum culture, the current gold standard, suffers from prolonged turnaround times (24-48 hours) and limited sensitivity for diverse bacterial pathogens, often delaying targeted antibiotic therapy and impacting patient outcomes. To address these limitations, the Biofire® FilmArray Pneumonia Panel (BFPP) has emerged as a potential rapid and comprehensive alternative. This rapid molecular diagnostic tool can detect a broad spectrum of bacterial and atypical pathogens within hours, facilitating faster initiation of appropriate antibiotics and potentially improving patient management. Aim of Work: This study aimed to assess the diagnostic value of BFPP compared to conventional sputum culture in critically ill patients with suspected pneumonia. Specifically, the study addressed the following objectives: A. Evaluate the diagnostic accuracy of BFPP for identifying bacterial pathogens compared to conventional sputum culture. B. Investigate the potential impact of BFPP on antibiotic management decisions. Subjects and Methods: This prospective, randomized controlled trial included 60 participants who randomly assigned to either group A (receiving routine diagnostic procedures) or group B (utilizing BFPP for bacterial and resistance gene detection). The study spanned six months. The study enrolled adults (age ≥ 18) critically ill with pneumonia, excluding those with pre-existing serious conditions like malignancies, lung injuries, atypical pneumonia, or immunodeficiency. Operational Design: • Initial Assessment: Comprehensive history taking, physical examination, BMI calculation • Investigations: Chest CT scan, complete blood count, CRP, procalcitonin level, and qSOFA score • Procedures: Antibiotic selection guided by microbiological culture results for both groups. Lab investigations and qSOFA scores repeated on day 5. Statistical analysis performed. • Outcomes: o Primary: The core objective is to assess the comparative abilities of BFPP and CSC in accurately detecting bacterial pathogens and resistance genes. The study investigates the potential association between the use of BFPP and and its relation to the ICU length of stay. This helps understand whether improved diagnostics translate into better patient outcomes. o Secondary: Early organism detection, appropriate antibiotic selection, ventilation days and overall antibiotic duration. Ethical Considerations: • Official permissions obtained from relevant authorities and Institutional Review Board. • Informed written consent acquired from all participants. • Adherence to international research ethics guidelines and declaration of no conflict of interest by the researcher. Results: Patients in group B had a significantly shorter ICU stay (6.10 vs. 9.37 days, p < 0.001). This suggests faster and more accurate diagnosis with BFPP potentially leading to better outcomes. Conclusion: Based on these results, implementing BFPP in clinical practice appears to encourage more precise and targeted antibiotic choices compared to traditional empirical prescribing based on clinical presentation. By guiding therapy towards narrower-spectrum antibiotics based on culture-specific guidance, BFPP holds promise for reducing unnecessary broad-spectrum use, potentially leading to improved patient outcomes and reduced risks of antibiotic resistance. Minimized side effects: Narrower-spectrum antibiotics often have fewer side effects compared to broad-spectrum agents. Potentially shorter treatment durations: Targeting the specific bacteria with a precise antibiotic may potentially shorten treatment times. This study demonstrates that BFPP offers a rapid and highly accurate alternative to conventional sputum culture for diagnosing bacterial pneumonia in critically ill patients. Further research is necessary to confirm these findings in larger populations and investigate the long-term clinical and economic implications of implementing BFPP in routine clinical practice. Limitation 1. Study duration: The six-month duration might not be sufficient to capture long-term impacts of BFPP implementation, such as its effect on antibiotic resistance patterns or healthcare costs over time. Further research with longer observation periods could provide more comprehensive insights. 2. Cost-effectiveness not assessed: The study didn’t analyze the cost-effectiveness of BFPP compared to conventional culture. This is crucial for determining the practicality and affordability of implementing BFPP on a larger scale. Recommendation Based on BFPP’s superior diagnostic performance: 1. Recommend routine implementation of BFPP in critically ill patients with suspected pneumonia admitted to the ICU. This could significantly improve patient outcomes by facilitating faster and more accurate diagnosis, leading to quicker initiation of appropriate antibiotics and potentially reducing unnecessary antibiotic use. 2. Advocate for further research on the long-term clinical and economic implications of incorporating BFPP into clinical practice. Consider investigating: Cost-effectiveness analyses comparing BFPP to conventional culture. Impact on antibiotic resistance patterns with the increased use of targeted therapy based on BFPP results. Potential reduction in ICU length of stay and overall healthcare costs with faster and more accurate diagnosis. |