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

Antimicrobial Agents and Chemotherapy

Volumn 53, Issue 7, 2009, Pages 2879-2886

  Weisman, Leonard E ^a   Thackray, Helen M ^b   Garcia Prats, Joseph A ^a   Nesin, Mirjana ^c   Schneider, Joseph H ^a   Fretz, Jennifer ^b   Kokai Kun, John F ^b   Mond, James J ^b   Kramer, William G ^d   Fischer, Gerald W ^b  

^a TEXAS CHILDREN S HOSPITAL   (United States)

^b Biosynexus Incorporated   (United States)

^c WEILL CORNELL MEDICAL COLLEGE   (United States)

^d Kramer Consulting LLC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BSYX A110; LIPOTEICHOIC ACID; MONOCLONAL ANTIBODY; PAGIBAXIMAB; PLACEBO; UNCLASSIFIED DRUG;

ALKALINE PHOSPHATASE BLOOD LEVEL; ANEMIA; ANTIBACTERIAL ACTIVITY; APNEA; ARTICLE; BLOODSTREAM INFECTION; BRAIN HEMORRHAGE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISTRIBUTION VOLUME; DOUBLE BLIND PROCEDURE; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GESTATIONAL AGE; HUMAN; HYPERBILIRUBINEMIA; HYPERKALEMIA; HYPONATREMIA; HYPOTENSION; IMMUNOGENICITY; MAJOR CLINICAL STUDY; MALE; NEUTROPENIA; NEWBORN; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY DISTRESS; SIDE EFFECT; STAPHYLOCOCCAL BACTEREMIA; THROMBOCYTOPENIA; UREA NITROGEN BLOOD LEVEL; VERY LOW BIRTH WEIGHT;

ANTIBODIES, MONOCLONAL; DOUBLE-BLIND METHOD; HUMANS; INFANT, NEWBORN; INFANT, VERY LOW BIRTH WEIGHT; STAPHYLOCOCCAL INFECTIONS;

EID: 67650000573     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.01565-08     Document Type: Article

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