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

Abstract

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.

• Authors: D K Benjamin, R Schelonka, R White, H P Holley, E Bifano, J Cummings, K Adcock, D Kaufman, B Puppala, P Riedel, B Hall, J White, C M Cotton, S. aureus prevention investigators
• Journal: Journal of perinatology : official journal of the California Perinatal Association (J Perinatol) Vol. 26 Issue 5 Pg. 290-5 (May 2006) ISSN: 0743-8346 [Print] United States
• PMID: 16598296 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Immunoglobulin G
• Immunologic Factors
• Polysaccharides, Bacterial
• capsular polysaccharide, type 5, Staphylococcus aureus
• capsular polysaccharide, type 8, Staphylococcus aureus

Topics

• Bacterial Capsules (immunology)
• Cross Infection (mortality, prevention & control)
• Double-Blind Method
• Female
• Humans
• Immunoglobulin G (administration & dosage, adverse effects, blood)
• Immunologic Factors (administration & dosage, adverse effects, blood)
• Infant, Newborn
• Infant, Very Low Birth Weight
• Injections, Intravenous
• Intensive Care Units, Neonatal
• Male
• Polysaccharides, Bacterial (immunology)
• Staphylococcal Infections (mortality, prevention & control)