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A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin.

Publication ,  Journal Article
Benjamin, DK; Schelonka, R; White, R; Holley, HP; Bifano, E; Cummings, J; Adcock, K; Kaufman, D; Puppala, B; Riedel, P; Hall, B; White, J ...
Published in: J Perinatol
May 2006

OBJECTIVES: 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.

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Published In

J Perinatol

DOI

ISSN

0743-8346

Publication Date

May 2006

Volume

26

Issue

5

Start / End Page

290 / 295

Location

United States

Related Subject Headings

  • Staphylococcal Infections
  • Polysaccharides, Bacterial
  • Pediatrics
  • Male
  • Intensive Care Units, Neonatal
  • Injections, Intravenous
  • Infant, Very Low Birth Weight
  • Infant, Newborn
  • Immunologic Factors
  • Immunoglobulin G
 

Citation

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Benjamin, D. K., Schelonka, R., White, R., Holley, H. P., Bifano, E., Cummings, J., … S. aureus prevention investigators, . (2006). A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin. J Perinatol, 26(5), 290–295. https://doi.org/10.1038/sj.jp.7211496
Benjamin, D. K., R. Schelonka, R. White, H. P. Holley, E. Bifano, J. Cummings, K. Adcock, et al. “A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin.J Perinatol 26, no. 5 (May 2006): 290–95. https://doi.org/10.1038/sj.jp.7211496.
Benjamin DK, Schelonka R, White R, Holley HP, Bifano E, Cummings J, et al. A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin. J Perinatol. 2006 May;26(5):290–5.
Benjamin, D. K., et al. “A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin.J Perinatol, vol. 26, no. 5, May 2006, pp. 290–95. Pubmed, doi:10.1038/sj.jp.7211496.
Benjamin DK, Schelonka R, White R, Holley HP, Bifano E, Cummings J, Adcock K, Kaufman D, Puppala B, Riedel P, Hall B, White J, Cotton CM, S. aureus prevention investigators. A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin. J Perinatol. 2006 May;26(5):290–295.

Published In

J Perinatol

DOI

ISSN

0743-8346

Publication Date

May 2006

Volume

26

Issue

5

Start / End Page

290 / 295

Location

United States

Related Subject Headings

  • Staphylococcal Infections
  • Polysaccharides, Bacterial
  • Pediatrics
  • Male
  • Intensive Care Units, Neonatal
  • Injections, Intravenous
  • Infant, Very Low Birth Weight
  • Infant, Newborn
  • Immunologic Factors
  • Immunoglobulin G