Methods: 1) Tracheal, dialysis and biliary catheters were charged with NO. NO+ and non-charged (NO-) control tracheal, and dialysis and biliary catheters were contaminated with Pseudomonas aeruginosa (102 CFU/ml) and Escherichia coli (101, 102 and 103CFU/ml) for 24-hour incubation period. Bacterial colonization onto catheters and planktonic growth in culture medium was assessed using standard plating methods. 2) Safety and tolerability of NO+ urinary catheters was assessed in 6 patients undergone radical prostatectomy catheterized for 7-21 days and followed for 50 days, and compared to 6 patients catheterized with NO- catheter. Safety was evaluated by the number of NO-related adverse events (AE's) and serious AEs (SAEs).
Results: 1) NO+ catheters prevented Pseudomonas aeruginosa and Escherichia coli colonization onto tracheal, and dialysis and biliary catheters, respectively. Inoculation of NO- dialysis and biliary catheters with 101, 102 and 103 CFU/ml of Escherichia coli resulted in up to 108 CFU/ml of planktonic bacteria in culture media. In contrast, NO+ dialysis catheters killed all planktonic bacteria at all inoculations, while NO+ biliary catheter killed all planktonic bacteria at 101 and 102 CFU/ml inoculations and reduced the number of planktonic bacteria by 3 logs at 103CFU/ml inoculation, in comparison to NO- control catheters. 2) All patients catheterized with NO+ catheter successfully completed the study without experiencing NO-related AE's such as priapism and local irritation. No differences in hematological, biochemical and coagulation parameters were detected between both groups throughout the study.
Conclusion: These data highlights the potential of NO-based platform technology as a safe and effective strategy for preventing catheter-associated HAI's.
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Y. Av-Gay, ENOX: Board Member and Shareholder , Licensing agreement or royalty
D. Margel, None