Anti-lipoteichoic acid monoclonal antibody (pagibaximab) studies for the prevention of staphylococcal bloodstream infections in preterm infants.
BACKGROUND
Advances in modern medicine have given very low birth weight (VLBW) infants a better chance of survival; however, these infants remain at high risk for developing nosocomial infections associated with increased morbidity and mortality. The ability of antistaphylococcal immunoglobulins, Altastaph and INH A-2, to augment the neonatal immune system to prevent infections has been studied and evaluated in a 2009 Cochrane review.


METHODS
Our objective is to evaluate the safety and efficacy of a third antistaphylococcal immunoglobulin, pagibaximab, in the prevention of staphylococcal infection in preterm infants. Three studies of pagibaximab, Phases I, II and III, were examined in terms of study design, pharmacokinetics, development of sepsis and adverse effects.


CONCLUSIONS
These studies demonstrated safety and tolerability of pagibaximab with no observed reduction in sepsis. Reported adverse events in both treatment and placebo groups were similar and consistent with events commonly observed in VLBW infants. Antistaphylococcal immunoglobulins alone have been unsuccessful in preventing nosocomial infections. Further investigations need to evaluate any potential immunomodulating products in preterm animal models prior to human studies. Future studies are required to determine how to best augment the immature immune system, likely through the use of multiple immunomodulating agents to successfully prevent infections in preterm infants.
Department of Pediatrics, Division of Neonatology, University of Virginia School of Medicine , Charlottesville, VA , USA +1 434 924 5428; +1 434 924 2816; mp4fb@virginia.edu.
Manisha
M
Patel
David A
DA
Kaufman
D000818:Animals; D000911:Antibodies, Monoclonal / Q000494:pharmacology / Q000627:therapeutic use*; D016470:Bacteremia / Q000175:diagnosis / Q000517:prevention & control; D002986:Clinical Trials as Topic / Q000379:methods; D003428:Cross Infection / Q000175:diagnosis / Q000517:prevention & control*; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature / Q000097:blood; D019102:Infant, Very Low Birth Weight / Q000097:blood; D008070:Lipopolysaccharides / Q000037:antagonists & inhibitors* / Q000378:metabolism; D018805:Sepsis / Q000175:diagnosis / Q000517:prevention & control*; D013203:Staphylococcal Infections / Q000175:diagnosis / Q000517:prevention & control*; D013682:Teichoic Acids / Q000037:antagonists & inhibitors* / Q000378:metabolism
D000911:Antibodies, Monoclonal; D008070:Lipopolysaccharides; D013682:Teichoic Acids; C524976:pagibaximab; C009900:lipoteichoic acid
anti-lipoteichoic acid; pagibaximab; preterm infants; prevention; staphylococcal infections