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A phase II multicenter, double-blind, randomized, placebo-controlled study of three dosages of an immunomodulator
T J Babineau1, A Hackford, A Kenler
1Department of Surgery, Deaconess Hospital, Harvard Medical School, Boston.
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.