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Immunoprophylaxis against klebsiella and pseudomonas aeruginosa infections. The Federal Hyperimmune Immunoglobulin Trial Study Group.

Author(s): Donta ST, Peduzzi P, Cross AS, Sadoff J, Haakenson C, Cryz SJ Jr, Kauffman C, Bradley S, Gafford G, Elliston D, Beam TR Jr, John JF Jr, Ribner B, Cantey R, Welsh CH, Ellison RT 3rd, Young EJ, Hamill RJ, Leaf H, Schein RM, Mulligan M, Johnson C, Abrutyn E, Griffiss JM, Slagle D

Affiliation(s): VA Medical Center, Boston, Massachusetts 02130, USA.

Publication date & source: 1996-09, J Infect Dis., 174(3):537-43.

Publication type: Clinical Trial; Randomized Controlled Trial

To determine if passive immunization could decrease the incidence or severity of Klebsiella and Pseudomonas aeruginosa infections, patients admitted to intensive care units of 16 Department of Veterans Affairs and Department of Defense hospitals were randomized to receive either 100 mg/kg intravenous hyperimmune globulin (IVIG), derived from donors immunized with a 24-valent Klebsiella capsular polysaccharide plus an 8-valent P. aeruginosa O-polysaccharide-toxin A conjugate vaccine, or an albumin placebo. The overall incidence and severity of vaccine-specific Klebsiella plus Pseudomonas infections were not significantly different between the groups receiving albumin and IVIG. There was some evidence that IVIG may decrease the incidence (2.7% albumin vs. 1.2% IVIG) and severity (1.0% vs. 0.3%) of vaccine-specific Klebsiella infections, but these reductions were not statistically significant. The trial was stopped because it was statistically unlikely that IVIG would be protective against Pseudomonas infections at the dosage being used. Patients receiving IVIG had more adverse reactions (14.4% vs. 9.2%).

Page last updated: 2006-11-04

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