Late Breaking Abstract - A phase I feasibility study in establishing the role of ultrasound-guided pleural biopsies in pleural infection (The AUDIO study)

Abstract

Background: Pleural infection is a common complication of pneumonia associated with high mortality and poor clinical outcome. We performed a feasibility interventional clinical trial assessing the safety and significance of ultrasound (US)-guided pleural biopsy culture to increase the microbiological yield. Methods: 20 patients with established pleural infection were recruited. Participants underwent a detailed US and US-guided pleural biopsies before chest drain insertion, alongside standard clinical management. Pleural biopsies and routine clinical samples were submitted for microbiological analysis. In an exploratory sub-study, the 16S rRNA technique was applied on pleural biopsy samples, to investigate its’ utility on increasing speed and accuracy versus standard microbiological diagnosis. Findings US-guided were safe with no adverse events observed in this study. Pleural biopsies increased microbiological yield by 30% in addition to pleural fluid and blood samples. The 16S rRNA technique was successfully applied to pleural biopsy samples, demonstrating high sensitivity (93%) and specificity (89·5%). Interpretation Our findings demonstrate safety of conducting US guided biopsies in patients with pleural infection and a substantial increase in microbiological diagnosis. qPCR primer assessment of pleural fluid and biopsy appears to have excellent sensitivity and specificity.