Phase 1/2 double-blind, placebo-controlled, dose escalation, safety, and pharmacokinetic study of pagibaximab (BSYX-A110), an antistaphylococcal monoclonal antibody for the prevention of staphylococcal bloodstream infections, in very-low-birth-weight neonates.

@article{Weisman2009Phase1D,
  title={Phase 1/2 double-blind, placebo-controlled, dose escalation, safety, and pharmacokinetic study of pagibaximab (BSYX-A110), an antistaphylococcal monoclonal antibody for the prevention of staphylococcal bloodstream infections, in very-low-birth-weight neonates.},
  author={Leonard E. Weisman and Helen M Thackray and Joseph A. Garcia-Prats and Mirjana Nesin and Joseph H Schneider and Jennifer Fretz and John F Kokai-Kun and James J. Mond and William G. Kramer and Gerald W. Fischer},
  journal={Antimicrobial agents and chemotherapy},
  year={2009},
  volume={53 7},
  pages={2879-86}
}
Staphylococcal sepsis is a major cause of morbidity and mortality in very-low-birth-weight (VLBW) infants. A human chimeric monoclonal antibody, pagibaximab, was developed against staphylococcal lipoteichoic acid. We evaluated the safety, tolerability, and pharmacokinetics of pagibaximab in VLBW neonates. A phase 1/2, randomized, double-blind, placebo-controlled, dose escalation study was conducted in VLBW infants (700 to 1,300 g) 3 to 7 days old. Patients received two doses 14 days apart of… CONTINUE READING

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