A phase II multicenter, double-blind, randomized, placebo-controlled study of three dosages of an immunomodulator (PGG-glucan) in high-risk surgical patients.

OBJECTIVE

To examine the safety and efficacy of multiple doses of PGG-glucan (poly-[1-6]-B-D-glucopyranosyl-[1-3]-B-D-glucopyranose) in high-risk patients undergoing major thoracic or abdominal surgery.

DESIGN

An interventional, multicenter, double-blind, randomized, placebo-controlled study.

SETTING

Four university-affiliated medical centers.

PATIENTS

Sixty-seven high-risk patients undergoing major thoracic or abdominal surgery.

INTERVENTION

Patients were randomized in a 1:1:1:1 ratio to receive saline placebo or PGG-glucan at a dose of 0.1 mg/kg, 0.5 mg/kg, and 1.0 mg/kg or 2.0 mg/kg. One dose was administered before surgery and three doses were administered after surgery.

MAIN OUTCOME MEASURES

To examine the safety and efficacy of PGG-glucan infusion and to identify potentially important factors for a planned phase III study.

RESULTS

A dose-response trend with regard to infection incidence among patients who received PGG-glucan was observed. Serious infections occurred in four patients who received placebo and in three patients who received PGG-glucan at a dose of 0.1 mg/kg. However, only one patient who received PGG-glucan at a high dose had a serious infection. The incidence and severity of adverse events was comparable in all groups.

CONCLUSIONS

PGG-glucan was generally safe and well tolerated, may decrease postoperative infection rates, and warrants further investigation in a planned phase III trial.