IMMUNOGLOBULIN COATINGS TO PREVENT CATHETER INFECTION

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Catheters are one of the most commonly used biomaterial implants, (200 million annually in the U.S.). In long term use as for vascular central lines, the urinary tract and peritoneal dialysis, catheters are particularly susceptible to infection. These infections are resistant to antibiotic treatment and persist until removal of the device. Utilizing the concept of Passive Local Immunotherapy, (PLI), we have demonstrated in animal models that biomaterial associated bacterial infections can be prevented through the direct local application of Human immunoglobulin, (IgG), natural antibodies, to biomaterial surfaces. Immunoglobulins in situ opsonize bacteria on arrival or shortly thereafter. Bacteria are identified and targeted for neutrophil and macrophage phagocytosis and killing while bacteria numbers are low and before they can propagate, release toxins, destroy tissue and form protective biofilms. IgG. also neutralizes bacterial toxins. The objective of this study is to demonstrate the efficacy in vitro and in vivo of local IgG coatings to catheter materials in blocking adhesion, colonization and biofilm type infection by clinically relevant strains of S. epidermidis and P. aetuginosa. The IgG prophylaxis/therapeutic is known to be safe (viral inactivated and FDA approved for i.v.use). Advantages of IgG coatings over current treatments are broad spectrum efficacy,independent of antibiotic resistance mechanisms (e.g. methicillin and vancomycin resistant Staphylococci), and cost- effectiveness. PROPOSED COMMERCIAL APPLICATION: The coating of catheters with IgG preparations will increase their resistance to bacterial infection. The New England Journal of Medicine attributes 50,000 deaths a year in the U.S. to catherization procedures at a cost exceeding $1.2 billion.