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Phase II, randomized, multicenter, double-blind, placebo-controlled trial of a polyclonal anti-Staphylococcus aureus capsular polysaccharide immune globulin in treatment of Staphylococcus aureus bacteremia.

Publication ,  Journal Article
Rupp, ME; Holley, HP; Lutz, J; Dicpinigaitis, PV; Woods, CW; Levine, DP; Veney, N; Fowler, VG
Published in: Antimicrob Agents Chemother
December 2007

New treatment modalities are needed for the treatment of infections due to multidrug-resistant Staphylococcus aureus. S. aureus capsular polysaccharide immune globulin (Altastaph) is a polyclonal immune globulin preparation that is being developed as adjunctive therapy for persons with S. aureus infections complicated by bacteremia. In a phase II, multicenter, randomized, double-blind, placebo-controlled trial, 40 subjects with documented S. aureus bacteremia received standard therapy plus either Altastaph at 200 mg/kg of body weight in each of two infusions 24 h apart or placebo. During the 42-day observation period, antibody pharmacokinetics and safety were the primary characteristics studied. Information regarding the resolution of bacteremia and fever was also analyzed. Anti-type-5 and anti-type-8 capsular antibody levels peaked after the second infusion at 550 mug/ml and 419 mug/ml, respectively, and remained above 100 mug/ml at day 28. A total of 316 adverse events were noted in 39 of 40 subjects. Infusion-related adverse events in Altastaph recipients were infrequent and similar to those among recipients of commercial intravenously administered immunoglobulin G products. Five of 21 (23%) subjects in the Altastaph group died, whereas 2 of 18 (11%) subjects in the placebo group died (P = 0.42). Compared to the control patients, the Altastaph recipients had a shorter median time to the resolution of fever (2 days and 7 days, respectively; P = 0.09) and a shorter length of hospital stay (9 days and 14 days, respectively; P = 0.03). However, these findings are exploratory, and there were few differences in the other variables measured. High levels of opsonizing antibodies were maintained for the initial 4 weeks. Although the study was not powered to show efficacy, these preliminary findings and safety profile suggest that Altastaph may be an effective adjunct to antibiotics and warrants further investigation (ClinicalTrials.gov number NCT00063089).

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Published In

Antimicrob Agents Chemother

DOI

ISSN

0066-4804

Publication Date

December 2007

Volume

51

Issue

12

Start / End Page

4249 / 4254

Location

United States

Related Subject Headings

  • Tachycardia
  • Staphylococcus aureus
  • Staphylococcal Infections
  • Polysaccharides, Bacterial
  • Placebos
  • Middle Aged
  • Microbiology
  • Male
  • Length of Stay
  • Infusions, Intravenous
 

Citation

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Rupp, M. E., Holley, H. P., Lutz, J., Dicpinigaitis, P. V., Woods, C. W., Levine, D. P., … Fowler, V. G. (2007). Phase II, randomized, multicenter, double-blind, placebo-controlled trial of a polyclonal anti-Staphylococcus aureus capsular polysaccharide immune globulin in treatment of Staphylococcus aureus bacteremia. Antimicrob Agents Chemother, 51(12), 4249–4254. https://doi.org/10.1128/AAC.00570-07
Rupp, Mark E., H Preston Holley, Jon Lutz, Peter V. Dicpinigaitis, Christopher W. Woods, Donald P. Levine, Naomi Veney, and Vance G. Fowler. “Phase II, randomized, multicenter, double-blind, placebo-controlled trial of a polyclonal anti-Staphylococcus aureus capsular polysaccharide immune globulin in treatment of Staphylococcus aureus bacteremia.Antimicrob Agents Chemother 51, no. 12 (December 2007): 4249–54. https://doi.org/10.1128/AAC.00570-07.
Rupp ME, Holley HP, Lutz J, Dicpinigaitis PV, Woods CW, Levine DP, Veney N, Fowler VG. Phase II, randomized, multicenter, double-blind, placebo-controlled trial of a polyclonal anti-Staphylococcus aureus capsular polysaccharide immune globulin in treatment of Staphylococcus aureus bacteremia. Antimicrob Agents Chemother. 2007 Dec;51(12):4249–4254.

Published In

Antimicrob Agents Chemother

DOI

ISSN

0066-4804

Publication Date

December 2007

Volume

51

Issue

12

Start / End Page

4249 / 4254

Location

United States

Related Subject Headings

  • Tachycardia
  • Staphylococcus aureus
  • Staphylococcal Infections
  • Polysaccharides, Bacterial
  • Placebos
  • Middle Aged
  • Microbiology
  • Male
  • Length of Stay
  • Infusions, Intravenous