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

Danny K. Benjamin, Robert Schelonka, Robert White, H. Preston Holley, Ellen Bifano, James Cummings, K. Adcock, David Kaufman, Bhagya Puppala, Phillip Riedel, Brian Hall, Jennifer White, C. Michael Cotten, Kevin Anstrom, Mariya Charny, Vance Fowler, Laura Haubner, Gary Horwith, Michael LeBlanc, Hussain NaveedLu Ann Papile, Stephen Petrycki, Adam Rosenberg, Henry Rozycki, Timothy Stevens, Naomi Veney, Nadarasa Visveshwara, Jenne Zenge

Research output: Contribution to journalArticle

67 Citations (Scopus)

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 ≤ 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

Original languageEnglish (US)
Pages (from-to)290-295
Number of pages6
JournalJournal of Perinatology
Volume26
Issue number5
DOIs
StatePublished - May 2006
Externally publishedYes

Fingerprint

Multicenter Studies
Staphylococcus aureus
Immunoglobulins
Immunoglobulin G
Newborn Infant
Very Low Birth Weight Infant
Placebos
Cross Infection
Infection
Polysaccharides
Clinical Trials
Morbidity
Safety
Serum
altastaph
Staphylococcus aureus capsular polysaccharide type 5

Keywords

  • Bacteremia
  • Infants
  • IVIG
  • Prevention
  • Prophylaxis
  • Sepsis

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Pediatrics, Perinatology, and Child Health

Cite this

A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin. / Benjamin, Danny K.; Schelonka, Robert; White, Robert; Holley, H. Preston; Bifano, Ellen; Cummings, James; Adcock, K.; Kaufman, David; Puppala, Bhagya; Riedel, Phillip; Hall, Brian; White, Jennifer; Cotten, C. Michael; Anstrom, Kevin; Charny, Mariya; Fowler, Vance; Haubner, Laura; Horwith, Gary; LeBlanc, Michael; Naveed, Hussain; Papile, Lu Ann; Petrycki, Stephen; Rosenberg, Adam; Rozycki, Henry; Stevens, Timothy; Veney, Naomi; Visveshwara, Nadarasa; Zenge, Jenne.

In: Journal of Perinatology, Vol. 26, No. 5, 05.2006, p. 290-295.

Research output: Contribution to journalArticle

Benjamin, DK, Schelonka, R, White, R, Holley, HP, Bifano, E, Cummings, J, Adcock, K, Kaufman, D, Puppala, B, Riedel, P, Hall, B, White, J, Cotten, CM, Anstrom, K, Charny, M, Fowler, V, Haubner, L, Horwith, G, LeBlanc, M, Naveed, H, Papile, LA, Petrycki, S, Rosenberg, A, Rozycki, H, Stevens, T, Veney, N, Visveshwara, N & Zenge, J 2006, 'A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin', Journal of Perinatology, vol. 26, no. 5, pp. 290-295. https://doi.org/10.1038/sj.jp.7211496
Benjamin, Danny K. ; Schelonka, Robert ; White, Robert ; Holley, H. Preston ; Bifano, Ellen ; Cummings, James ; Adcock, K. ; Kaufman, David ; Puppala, Bhagya ; Riedel, Phillip ; Hall, Brian ; White, Jennifer ; Cotten, C. Michael ; Anstrom, Kevin ; Charny, Mariya ; Fowler, Vance ; Haubner, Laura ; Horwith, Gary ; LeBlanc, Michael ; Naveed, Hussain ; Papile, Lu Ann ; Petrycki, Stephen ; Rosenberg, Adam ; Rozycki, Henry ; Stevens, Timothy ; Veney, Naomi ; Visveshwara, Nadarasa ; Zenge, Jenne. / A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin. In: Journal of Perinatology. 2006 ; Vol. 26, No. 5. pp. 290-295.
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AU - Benjamin, Danny K.

AU - Schelonka, Robert

AU - White, Robert

AU - Holley, H. Preston

AU - Bifano, Ellen

AU - Cummings, James

AU - Adcock, K.

AU - Kaufman, David

AU - Puppala, Bhagya

AU - Riedel, Phillip

AU - Hall, Brian

AU - White, Jennifer

AU - Cotten, C. Michael

AU - Anstrom, Kevin

AU - Charny, Mariya

AU - Fowler, Vance

AU - Haubner, Laura

AU - Horwith, Gary

AU - LeBlanc, Michael

AU - Naveed, Hussain

AU - Papile, Lu Ann

AU - Petrycki, Stephen

AU - Rosenberg, Adam

AU - Rozycki, Henry

AU - Stevens, Timothy

AU - Veney, Naomi

AU - Visveshwara, Nadarasa

AU - Zenge, Jenne

PY - 2006/5

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N2 - 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 ≤ 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

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KW - Bacteremia

KW - Infants

KW - IVIG

KW - Prevention

KW - Prophylaxis

KW - Sepsis

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