RANDOMIZED PHASE I II TRIAL OF A MACROPHAGE-SPECIFIC IMMUNOMODULATOR (PGG-GLUCAN) IN HIGH-RISK SURGICAL PATIENTS/

Objective The safety and efficacy of PGG-glucan in surgical patients a t high risk for postoperative infection who underwent major thoracic o r abdominal surgery were determined. Summary Background Data Recent st udies have reported a 25% to 27% infectious complication rate in patie nts undergoing major surgery with an average cost per infected patient of $12,000. The efficacy of PGG-glucan pretreatment in prevention of sepsis has been demonstrated in rodent models for gram-negative and gr am-positive bacterial and yeast infections. In vitro studies have demo nstrated enhanced microbial killing by monocytes and neutrophils in he althy volunteers after PGG-glucan administration. Thus, PGG-glucan may play a role in decreasing the infectious complication rate in patient s undergoing major surgery. Methods A double-blind, placebo-controlled randomized study was performed in 34 high-risk patients undergoing ma jor abdominal or thoracic surgery. Results There were no adverse drug experiences associated with PGG-glucan infusion. Patients who received PGG-glucan had significantly fewer infectious complications (3.4 infe ctions per infected patient vs. 1.4 infections per infected patient, p = 0.05), decreased intravenous antibiotic requirement (10.3 days vs. 0.4 days, p = 0.04) and shorter intensive care unit length of stay (3. 3 days vs. 0.1 days, p = 0.03). Conclusions PGG-glucan is safe and app ears to be effective in the further reduction of the morbidity and cos t of major surgery.