The study will further evaluate the safety and efficacy of P1A administered in combination with Ampicillin in preventing the damage to the intestinal microflora caused by the residual beta-lactam antibiotic in hospitalized patients with upper and lower respiratory tract infections.
In the previous studies performed, P1A prevented the emergence of bacterial antibiotic resistance and depletion of healthy intestinal microflora, side effects commonly associated with antibiotic treatment. An excellent safety profile was also demonstrated in all patients treated with P1A.
In this study, the overgrowth of the intestinal microflora with pathogens as a consequence of microflora disturbance by administration of Ampicillin will be monitored.
About two million patients a year become infected while being treated for another illness or injury and over 90,000 die because of these infections. According to the Center for Disease Control and Prevention, 1.8 million of the infections occur in hospitals.
Ipsat expects that the clinical treatment phase of this trial will be completed by end of May 2007.