Document Detail

A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin.
MedLine Citation:
PMID:  16598296     Owner:  NLM     Status:  MEDLINE    
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.
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;
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Publication Detail:
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    
Journal Detail:
Title:  Journal of perinatology : official journal of the California Perinatal Association     Volume:  26     ISSN:  0743-8346     ISO Abbreviation:  J Perinatol     Publication Date:  2006 May 
Date Detail:
Created Date:  2006-04-25     Completed Date:  2006-09-20     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  8501884     Medline TA:  J Perinatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  290-5     Citation Subset:  IM    
Duke University Department of Pediatrics, Durham, NC 27710, USA.
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MeSH Terms
Bacterial Capsules / immunology
Cross Infection / mortality,  prevention & control*
Double-Blind Method
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
Polysaccharides, Bacterial / immunology
Staphylococcal Infections / mortality,  prevention & control*
Grant Support
1U10-HD45962-02/HD/NICHD NIH HHS; HD044799-01/HD/NICHD NIH HHS
Reg. No./Substance:
0/Bacterial Capsules; 0/Immunoglobulin G; 0/Immunologic Factors; 0/Polysaccharides, Bacterial; 0/capsular polysaccharide, type 5, Staphylococcus aureus; 0/capsular polysaccharide, type 8, Staphylococcus aureus

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