A randomized study of a monoclonal antibody (pagibaximab) to prevent staphylococcal sepsis

Pediatrics

Volumn 128, Issue 2, 2011, Pages 271-279

  Weisman, Leonard E ^a   Thackray, Helen M ^b   Steinhorn, Robin H ^c   Walsh, William F ^d   Lassiter, Herbert A ^e   Dhanireddy, Ramasubbareddy ^f   Brozanski, Beverly S ^g   Palmer, Kristine G H ^h   Trautman, Michael S ⁱ   Escobedo, Marilyn ^j   Meissner, H Cody ^k   Sasidharan, Pontthenkandath ^l   Fretz, Jennifer ^b   Kokai Kun, John F ^b   Kramer, William G ^m   Fischer, Gerald W ^b   Mond, James J ^b  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

^b Biosynexus Incorporated   (United States)

^c NORTHWESTERN UNIVERSITY   (United States)

^d VANDERBILT UNIVERSITY   (United States)

^e University of Louisville School of Medicine   (United States)

^f LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER   (United States)

^g UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^h UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES   (United States)

ⁱ INDIANA UNIVERSITY   (United States)

^j UNIVERSITY OF OKLAHOMA COLLEGE OF MEDICINE   (United States)

^k TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^l MEDICAL COLLEGE OF WISCONSIN   (United States)

^m Kramer Consulting LLC   (United States)

more..

Author keywords

Chimeric; Immunogenic; Immunoglobulin; Monoclonal antibody; Newborn; Nosocomial infection; Pharmacokinetics; Safety; Sepsis; Staphylococcus; Very low birth weight

Indexed keywords

PAGIBAXIMAB; PLACEBO;

ABDOMINAL DISTENSION; ANEMIA; APNEA; ARTICLE; BIRTH WEIGHT; BLOOD SAMPLING; BRADYCARDIA; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE COMPARISON; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HIGH RISK PATIENT; HUMAN; HYPONATREMIA; HYPOTENSION; INTESTINE PERFORATION; KIDNEY FAILURE; LEUKOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MORTALITY; NEWBORN; NEWBORN MORBIDITY; NEWBORN MORTALITY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY DISTRESS; SEPSIS; SIDE EFFECT; STAPHYLOCOCCUS; STAPHYLOCOCCUS INFECTION; THROMBOCYTOPENIA;

ANTIBODIES, MONOCLONAL; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INFANT, NEWBORN; INFANT, VERY LOW BIRTH WEIGHT; INFUSIONS, INTRAVENOUS; MALE; RISK FACTORS; SEPSIS; STAPHYLOCOCCAL INFECTIONS;

EID: 80051494427     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2010-3081     Document Type: Article

References (32)

1. Fanaroff AA, Korones SB, Wright LL, et al. Incidence, presenting features, risk factors and significance of late onset septicemia in very low birth weight infants. Pediatr Infect Dis J. 1998;17(7):593-598 (Pubitemid 28340869)
2. Gray JE, Richardson DK, McCormick MC, Goldmann DA. Coagulase-negative staphylococcal bacteremia among very low birth weight infants: relation to admission illness severity, resource use and outcome. Pediatrics. 1995;95(2):225-230
3. Gladstone IM, Ehrenkranz RA, Edberg SC, Baltimore RS. A ten-year review of neonatal sepsis and comparison with the previous fifty-year experience. Pediatr Infect Dis J. 1990;9(11):819-825 (Pubitemid 20385449)
4. Brodie SB, Sands KE, Gray JE, Parker RA, Goldmann DA, Davis RB, Richardson DK. Occurrence of nosocomial bloodstream infections in sixNICUs. Pediatr Infect Dis J. 2000;19(1):56-65 (Pubitemid 30046618)
5. Stoll BJ, Hansen N, Fanaroff AA, et al. Late-onset sepsis in very low birth weight neonates: the experience of the NICHD Neonatal Research Network. Pediatrics. 2002;110(2 pt 1):285-291 (Pubitemid 34833012)
6. Freeman J, Epstein MF, Smith NE, Platt R, Sidebottom DG, Goldmann DA. Extra hospital stay and antibiotic usage with nosocomial coagulase-negative staphylococcal bacteremia in two neonatal intensive care unit populations. Am J Dis Child. 1990;144(3):324-329 (Pubitemid 20067058)
7. Eady EA, Cove JH. Staphylococcal resistance revisited: community-acquired methicillin resistant Staphylococcus aureus - an emerging problem for the management of skin and soft tissue infections. Curr Opin Infect Dis. 2003;16(2):103-124 (Pubitemid 36521023)
8. Smith TL, Pearson ML, Wilcox KR, et al. Emergence of vancomycin resistance in Staphylococcus aureus. N Engl J Med. 1999;340(7):493-501 (Pubitemid 29093284)
9. Srinivasan A, Dick JD, Perl TM. Vancomycin resistance in staphylococci. Clin Microbiol Rev. 2002;15(3):430-438 (Pubitemid 34761351)
10. Tegnell A, Grabowska K, Jacobsson A, Andersson M, Giesecke J, Ohman L. Study of developed resistance due to antibiotic treatment of coagulase-negative staphylococci. Microb Drug Resist. 2003;9(1):1-6 (Pubitemid 36403052)
11. Gründling A, Schneewind O. Synthesis of glycerol phosphate lipoteichoic acid in Staphylococcus aureus. Proc Natl Acad Sci. 2007;104(20):8478-8483 (Pubitemid 47175513)
12. Neuhaus FC, Baddiley J. A continuum of anionic charge: structures and functions of D-alanyl-teichoic acids in gram-positive bacteria. Microbiol Mol Biol Rev. 2003;67(4):686-723 (Pubitemid 37549774)
13. Raynor RH, Scott DF, Best GK. Lipoteichoic acid inhibition of phagocytosis of Staphylococcus aureus by human polymorphonuclear leukocytes. Clin Immunol Immunopathol. 1981;19(2):181-189 (Pubitemid 11097005)
14. Hermann C, Spreitzer I, Schröder NWJ, et al. Cytokine induction by purified lipoteichoic acids from various bacterial species: role of LBP, sCD14, CD14 and failure to induce IL-12 and subsequent IFN-γrelease (p 541-551). Eur J Immunol. 2002;32(2):541-551 (Pubitemid 34173345)
15. Ginsburg I. Role of lipoteichoic acid in infection and inflammation. Lancet Infect Dis. 2002;2(3):171-179 (Pubitemid 34462452)
16. Weisman LE, Thackray HM, Garcia-Prats JA, et al. Phase 1/2 double-blind placebo-controlled, dose escalation, safety, and pharmacokinetic study of pagibaximab (BSYX-A110), an anti-staphylococcal monoclonal antibody for the prevention of staphylococcal bloodstream infections in very low birth weight neonates. Antimicrob Agents Chemother. 2009;53(7):2879-2886
17. Weisman LE, Fischer GW, Thackray HM, et al. Safety and pharmacokinetics of a chimerized anti-lipoteichoic acid monoclonal antibody in healthy adults. Int Immunopharmacol. 2009;9(5):639-644
18. US Food and Drug Administration. Guideline for industry clinical safety data management: definitions and standards for expedited reporting. Updated March 1995. Available at: www.fda.gov/downloads/regulatoryinformation/guidances/ UCM129518.pdf. Accessed June 14, 2011
19. Fischer GW, Cieslak TJ, Wilson SR, Weisman LE, Hemming VG. Opsonic antibodies to Staphylococcus epidermidis: in vitro and in vivo studies using human intravenous immune globulin. J Infect Dis. 1994;169(2):324-329 (Pubitemid 24045591)
20. Kloos WE, Wolfshohi F. Identification of Staphylococcus species with the API STAPHIDENT system. J Clin Microbiol. 1982;16(3):509-516 (Pubitemid 12050045)
21. Linhardt F, Ziebuhr W, Meyer P, Witte W, Hacker J. Pulsed-field gel electrophoresis of genomic restriction fragments as a tool for the epidemiologic analysis of Staphylococcus aureus and coagulase-negative staphylococci. FEMS Microbiol Lett. 1992;74(2-3):181-185
22. Subramanian KN, Weisman LE, Rhodes T, et al. Safety, tolerance and pharmacokinetics of a humanized monoclonal antibody to respiratory syncytial virus in premature infants and infants with bronchopulmonary dysplasia. Pediatr Infect Dis J. 1998;17(2):110-115 (Pubitemid 28096007)
23. Greenberg JW, Fischer W, Joiner KA. Influence of lipoteichoic acid structure on recognition by the macrophage scavenger receptor. Infect Immun. 1996;64(8):3318-3325 (Pubitemid 26256182)
24. DeKimpe, SJ, Kengatharan M, Thierermann C, Vane JR. The cell wall components peptidoglycan and lipoteichoic acid from Staphylococcus aureus act in synergy to cause shock and multiple organ failure. Proc Natl Acad Sci U S A. 1995;92(22):10359-10363
25. Kengatharan KM, DeKimpe S, Robson C, Foster SJ, Thiermann C. Mechanism of grampositive shock: identification of peptidoglycan and lipoteichoic acid moieties essential in the induction of nitric oxide synthase, shock, and multiple organ failure. J Exp Med. 1998;188(2):305-315 (Pubitemid 28357759)
26. Kimbrell MR, Warshakoon H, Cromer JR, et al. Comparison of the immunostimulatory and proinflammatory activities of candidate Gram-positive endotoxins, lipoteichoic acid, peptidoglycan, and lipopeptides, in murine and human cells. Immunol Lett. 2008;118(2):132-141
27. Fanaroff AA, Korones SB, Wright LL, et al Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. A controlled trial of intravenous immune globulin to reduce nosocomial infections in very-low-birth-weight infants. N Engl J Med. 1994;330(16):1107-1113 (Pubitemid 24118267)
28. Nurkka A, Lehtonen H, Vuorela A, Ekstrom N, Kayhty H. Functionality of antibodies against serotypes 6A and 19A induced by three different pneumococcal conjugate vaccines (PCV) in infants. Presented at: 5th International Symposium on Pneumococci and Pneumococcal Diseases; Alice Springs, Australia: April 2-6, 2006
29. Weisman LE, Stoll BJ, Kueser TJ, et al. Intravenous immune globulin prophylaxis of late-onset sepsis in premature neonates. J Pediatr. 1994;125(6 pt 1):922-930 (Pubitemid 24379129)
30. Lamari F, Anastssiou ED, Stamakosta E, et al. Determination of slime-producing S epidermidis specific antibodies in human Ig preparations and blood sera by an ELISA: correlation of antibody titers with opsonic activity and application to preterm neonates. J Pharm Biomed Anal. 2000;23(2-3):363-374 (Pubitemid 30599449)
31. DeJonge M, Burchfield D, Bloom B, et al. Clinical trial of safety and efficacy of INH-A21 for the prevention of nosocomial staphylococcal bloodstream infection in premature infants. J Pediatr. 2007;151(3):260-265, 265.e1
32. Nimmerjahn JV, Ravetch JV. Fcgamma receptors: old friends and new family members. Immunity. 2006;24(1):19-28 (Pubitemid 43077197)