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Phase II, randomized, double-blind, multicenter study comparing the safety and pharmacokinetics of tefibazumab to placebo for treatment of Staphylococcus aureus bacteremia.

Publication ,  Journal Article
Weems, JJ; Steinberg, JP; Filler, S; Baddley, JW; Corey, GR; Sampathkumar, P; Winston, L; John, JF; Kubin, CJ; Talwani, R; Moore, T; Patti, JM ...
Published in: Antimicrob Agents Chemother
August 2006

Tefibazumab (Aurexis), a humanized monoclonal antibody that binds to the surface-expressed adhesion protein clumping factor A, is under development as adjunctive therapy for serious Staphylococcus aureus infections. Sixty patients with documented S. aureus bacteremia (SAB) were randomized and received either tefibazumab at 20 mg/kg of body weight as a single infusion or a placebo in addition to an antibiotic(s). The primary objective of the study was determining safety and pharmacokinetics. An additional objective was to assess activity by a composite clinical end point (CCE). Baseline characteristics were evenly matched between groups. Seventy percent of infections were healthcare associated, and 57% had an SAB-related complication at baseline. There were no differences between the treatment groups in overall adverse clinical events or alterations in laboratory values. Two patients developed serious adverse events that were at least possibly related to tefibazumab; one hypersensitivity reaction was considered definitely related. The tefibazumab plasma half-life was 18 days. Mean plasma levels were <100 microg/ml by day 14. A CCE occurred in six patients (four placebo and two tefibazumab patients) and included five deaths (four placebo and one tefibazumab patient). Progression in the severity of sepsis occurred in four placebo and no tefibazumab patients. Tefibazumab was well tolerated, with a safety profile similar to those of other monoclonal antibodies. Additional trials are warranted to address the dosing range and efficacy of tefibazumab.

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Published In

Antimicrob Agents Chemother

DOI

ISSN

0066-4804

Publication Date

August 2006

Volume

50

Issue

8

Start / End Page

2751 / 2755

Location

United States

Related Subject Headings

  • Staphylococcus aureus
  • Staphylococcal Infections
  • Middle Aged
  • Microbiology
  • Male
  • Humans
  • Female
  • Double-Blind Method
  • Bacteremia
  • Area Under Curve
 

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Weems, J. J., Steinberg, J. P., Filler, S., Baddley, J. W., Corey, G. R., Sampathkumar, P., … Fowler, V. G. (2006). Phase II, randomized, double-blind, multicenter study comparing the safety and pharmacokinetics of tefibazumab to placebo for treatment of Staphylococcus aureus bacteremia. Antimicrob Agents Chemother, 50(8), 2751–2755. https://doi.org/10.1128/AAC.00096-06
Weems, J John, James P. Steinberg, Scott Filler, John W. Baddley, G Ralph Corey, Priya Sampathkumar, Lisa Winston, et al. “Phase II, randomized, double-blind, multicenter study comparing the safety and pharmacokinetics of tefibazumab to placebo for treatment of Staphylococcus aureus bacteremia.Antimicrob Agents Chemother 50, no. 8 (August 2006): 2751–55. https://doi.org/10.1128/AAC.00096-06.
Weems JJ, Steinberg JP, Filler S, Baddley JW, Corey GR, Sampathkumar P, et al. Phase II, randomized, double-blind, multicenter study comparing the safety and pharmacokinetics of tefibazumab to placebo for treatment of Staphylococcus aureus bacteremia. Antimicrob Agents Chemother. 2006 Aug;50(8):2751–5.
Weems, J. John, et al. “Phase II, randomized, double-blind, multicenter study comparing the safety and pharmacokinetics of tefibazumab to placebo for treatment of Staphylococcus aureus bacteremia.Antimicrob Agents Chemother, vol. 50, no. 8, Aug. 2006, pp. 2751–55. Pubmed, doi:10.1128/AAC.00096-06.
Weems JJ, Steinberg JP, Filler S, Baddley JW, Corey GR, Sampathkumar P, Winston L, John JF, Kubin CJ, Talwani R, Moore T, Patti JM, Hetherington S, Texter M, Wenzel E, Kelley VA, Fowler VG. Phase II, randomized, double-blind, multicenter study comparing the safety and pharmacokinetics of tefibazumab to placebo for treatment of Staphylococcus aureus bacteremia. Antimicrob Agents Chemother. 2006 Aug;50(8):2751–2755.

Published In

Antimicrob Agents Chemother

DOI

ISSN

0066-4804

Publication Date

August 2006

Volume

50

Issue

8

Start / End Page

2751 / 2755

Location

United States

Related Subject Headings

  • Staphylococcus aureus
  • Staphylococcal Infections
  • Middle Aged
  • Microbiology
  • Male
  • Humans
  • Female
  • Double-Blind Method
  • Bacteremia
  • Area Under Curve