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.


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


METHODS
Four university-affiliated medical centers.


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


METHODS
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.


METHODS
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.
Babineau
T J
TJ
Department of Surgery, Deaconess Hospital, Harvard Medical School, Boston.
Hackford
A
A
Kenler
A
A
Bistrian
B
B
Forse
R A
RA
Fairchild
P G
PG
Heard
S
S
Keroack
M
M
Caushaj
P
P
Benotti
P
P
D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D001424:Bacterial Infections / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005936:Glucans / Q000008:administration & dosage*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control*; D011292:Premedication; D047071:beta-Glucans
D000276:Adjuvants, Immunologic; D005936:Glucans; D047071:beta-Glucans; C069894:poly-1-6-glucopyranosyl-1-3-glucopyranose glucan