A PHASE II STUDY OF CHIMERIC MONOCLONAL ANTIBODIES TO SHIGA TOXINS 1 (C?STX1) AND 2 (C?STX2) ADMINISTERED CONCOMITANTLY TO CHILDREN WITH SHIGA TOXIN-PRODUCING BACTERIAL (STPB) INFECTION AND BLOODY DIARRHEA (SHIGATEC TRIAL)

Thallion Pharmaceuticals, Inc,0 个研究点目标入组 0 人开始时间: 2010年8月10日最近更新: 2023年9月4日

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•1)Written, signed and dated informed consent by a parent or legally acceptable representative and age appropriate patient assent
•2)Age between 6 months and 18 years (inclusively)
•3)Bloody diarrhea (by visual inspection) for no more than 36 hours prior to screening.
•4)Females of child-bearing potential and sexually active must have a negative urine pregnancy test prior to administration of study medication. Abstain from sexual activity or use of acceptable contraceptive measures.
•5)Detection of Shiga toxin (Stx1 and/or Stx2) in stool by a rapid diagnostic test (Meridian Premier EHEC Assay) or antigens from Shiga toxin producing E. Coli 0157 (ImmunoCard STAT E. coli 0157 Plus test)

•1)Laboratory findings compatible with development of at least two out of the three following criteria that define HUS: hemolytic anemia, thrombocytopenia and nephropathy
•2)Bloody-diarrhea suspected not to be caused by STPB but by other organisms or preexisting diseases
•3)History of renal disease or malformation. Active renal disease including infection, and isolated macrohematuria
•4)Family history of proven or suspected hereditary HUS or TTP
•5)Clinically significant and/or uncontrolled cardiovascular, hepatic, pulmonary, gastrointestinal, endocrine, metabolic, ophthalmologic, immunologic or other significant disease
•6)History of chronic/recurrent hemolytic anemia or thrombocytopenia
•7)Ongoing treatment for malignancy
•8)History of chronic inflammatory bowel disease
•9)Prior treatment with murine, chimeric, or humanized antibody
•10)Breastfeeding women
•11)Simultaneous participation in another interventional clinical research study.
•12)Any medical or social condition which in the opinion of the investigator would interfere with optimal participation in the study or produce a significant risk to the patient.

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