title: A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin.
abstract: OBJECTIVE
  Very low birth weight (VLBW) infants are vulnerable to nosocomial infections and subsequent morbidity; including infections caused by Staphylococcus aureus: 85% of nosocomial S. aureus infections are caused by capsular polysaccharide (CPS) types 5 and 8. Altastaph is a polyclonal investigational human immunoglobulin G (IgG) with high levels of opsonizing S. aureus CPS types 5 and 8 IgG.
  
  
  METHODS
  A Phase 2 clinical trial to assess the safety and kinetics of Altastaph in VLBW infants. Neonates in this multicenter study were randomized to receive two identical 20 ml/kg i.v. infusions of either 0.45% NaCl placebo or 1000 mg Altastaph/kg. Each infant was followed for 28 days after the second infusion or until discharge. Serum S. aureus CPS types 5 and 8 IgG levels were measured preinfusion and at various times after each infusion.
  
  
  RESULTS
  Of 206 neonates, 158 received both infusions. Adverse events were similar in the two treatment groups. Six subjects (3% in each group) discontinued owing to an adverse event. Geometric mean anti-type 5 IgG levels were 402 and 642 mcg/ml 1 day following infusion of the first (day 0) and Second (day 14) doses, respectively, in neonates < or =1000 g and slightly higher in neonates 1001 to 1500 g. Trough levels before second infusion were 188 mcg/ml. Type 8 IgG levels were similar. Geometric mean IgG levels among placebo recipients were consistently <2 and <5 mcg/ml for types 5 and 8 in both weight groups. Three episodes of S. aureus bacteremia occurred in each arm.
  
  
  CONCLUSIONS
  Infusion of Altastaph in VLBW neonates resulted in high levels of specific S. aureus types 5 and 8 CPS IgG. The administration of this anti-staphylococcal hyperimmune globulin was well tolerated in this population.
authors.affiliation: Duke University Department of Pediatrics, Durham, NC 27710, USA. danny.benjamin@duke.edu
authors.forename: D K
authors.initials: DK
authors.lastname: Benjamin
authors.forename: R
authors.initials: R
authors.lastname: Schelonka
authors.forename: R
authors.initials: R
authors.lastname: White
authors.forename: H P
authors.initials: HP
authors.lastname: Holley
authors.forename: E
authors.initials: E
authors.lastname: Bifano
authors.forename: J
authors.initials: J
authors.lastname: Cummings
authors.forename: K
authors.initials: K
authors.lastname: Adcock
authors.forename: D
authors.initials: D
authors.lastname: Kaufman
authors.forename: B
authors.initials: B
authors.lastname: Puppala
authors.forename: P
authors.initials: P
authors.lastname: Riedel
authors.forename: B
authors.initials: B
authors.lastname: Hall
authors.forename: J
authors.initials: J
authors.lastname: White
authors.forename: C M
authors.initials: CM
authors.lastname: Cotton
mesh_terms: D016667:Bacterial Capsules / Q000276:immunology; D003428:Cross Infection / Q000401:mortality / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D007155:Immunologic Factors / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D007231:Infant, Newborn; D019102:Infant, Very Low Birth Weight; D007275:Injections, Intravenous; D007363:Intensive Care Units, Neonatal; D008297:Male; D011135:Polysaccharides, Bacterial / Q000276:immunology; D013203:Staphylococcal Infections / Q000401:mortality / Q000517:prevention & control*
chemical_list: D007074:Immunoglobulin G; D007155:Immunologic Factors; D011135:Polysaccharides, Bacterial; C054106:capsular polysaccharide, type 5, Staphylococcus aureus; C064836:capsular polysaccharide, type 8, Staphylococcus aureus