Photodynamic Treatment of Endotracheal Tube Biofilms

DESCRIPTION (provided by applicant): Ventilator-associated pneumonia (VAP) is a common, significant, life threatening and unaddressed infectious disease problem that occurs in patients who are intubated with an endotracheal tube and require mechanical ventilation. Of the l .6 million patients per year in the US who require mechanical ventilation, 15-25% will develop VAP and 24-71% will die of the disease. In addition, VAP costs the US healthcare industry $1.2 billion dollars annually. A major cause of VAP is the proliferation of microorganisms and microbial biofilm on the interior of the endotracheal tube, which during mechanical ventilation is dislodged into the lung resulting in tracheobronchitis and pneumonia. The primary objective of the proposed SBIR-AT-NIAID project is to perform a controlled, double armed, multi-institutional IRB approved human clinical trial to determine the safety and efficacy of using Photodynamic Therapy (PDT) to reduce endotracheal tube microorganisms and associated biofilm. The reduction of the endotracheal tube microorganisms is expected to result in a significant reduction of the incidence of VAP with reduced morbidity, mortality, length of hospital stay and overall cost of treatment. PDT is a treatment modality that combines the use of a photosensitizing solution and light to create oxygen radicals resulting in the destruction of microorganisms. Advanced Photodynamic Technologies, Inc. has developed and optimized a PDT System that has been proven to be effective in the broad spectrum eradication of antibiotic resistant pathogenic bacteria, fungi and biofilms during in vitro, ex vivo and in vivo experiments. In addition, the safety of the proposed photosensitizer solution and light combination has been established in a GLP controlled large mammal study. The proposed clinical study will demonstrate the safety and efficacy of PDT treatment as a means to reduce endotracheal tube biofilm resulting in a reduction in the incidence of VAP. The proposed PDT System is unique in that no effective alternative treatment of endotracheal tube microbial biofilms is currently available for clinical use.