title: Immunoprophylaxis against klebsiella and pseudomonas aeruginosa infections. The Federal Hyperimmune Immunoglobulin Trial Study Group.
abstract: 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%).
authors.affiliation: VA Medical Center, Boston, Massachusetts 02130, USA.
authors.forename: S T
authors.initials: ST
authors.lastname: Donta
authors.forename: P
authors.initials: P
authors.lastname: Peduzzi
authors.forename: A S
authors.initials: AS
authors.lastname: Cross
authors.forename: J
authors.initials: J
authors.lastname: Sadoff
authors.forename: C
authors.initials: C
authors.lastname: Haakenson
authors.forename: S J
authors.initials: SJ
authors.lastname: Cryz
authors.forename: C
authors.initials: C
authors.lastname: Kauffman
authors.forename: S
authors.initials: S
authors.lastname: Bradley
authors.forename: G
authors.initials: G
authors.lastname: Gafford
authors.forename: D
authors.initials: D
authors.lastname: Elliston
authors.forename: T R
authors.initials: TR
authors.lastname: Beam
authors.forename: J F
authors.initials: JF
authors.lastname: John
authors.forename: B
authors.initials: B
authors.lastname: Ribner
authors.forename: R
authors.initials: R
authors.lastname: Cantey
authors.forename: C H
authors.initials: CH
authors.lastname: Welsh
authors.forename: R T
authors.initials: RT
authors.lastname: Ellison
authors.forename: E J
authors.initials: EJ
authors.lastname: Young
authors.forename: R J
authors.initials: RJ
authors.lastname: Hamill
authors.forename: H
authors.initials: H
authors.lastname: Leaf
authors.forename: R M
authors.initials: RM
authors.lastname: Schein
authors.forename: M
authors.initials: M
authors.lastname: Mulligan
authors.forename: C
authors.initials: C
authors.lastname: Johnson
authors.forename: E
authors.initials: E
authors.lastname: Abrutyn
authors.forename: J M
authors.initials: JM
authors.lastname: Griffiss
authors.forename: D
authors.initials: D
authors.lastname: Slagle
mesh_terms: D000907:Antibodies, Bacterial / Q000032:analysis / Q000097:blood; D004311:Double-Blind Method; D006801:Humans; D007116:Immunization, Passive; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000627:therapeutic use; D000922:Immunotoxins / Q000276:immunology; D007709:Klebsiella / Q000737:chemistry; D007710:Klebsiella Infections / Q000276:immunology* / Q000401:mortality / Q000517:prevention & control*; D019081:O Antigens / Q000276:immunology; D011135:Polysaccharides, Bacterial / Q000276:immunology; D011552:Pseudomonas Infections / Q000276:immunology* / Q000401:mortality / Q000517:prevention & control*; D011550:Pseudomonas aeruginosa / Q000737:chemistry
chemical_list: D000907:Antibodies, Bacterial; D016756:Immunoglobulins, Intravenous; D000922:Immunotoxins; D019081:O Antigens; D011135:Polysaccharides, Bacterial