None listed
Conditions
Interventions
The first 21 patients will be randomized in a ratio of 2:1 to one of the following two arms:
Experimental arm: Standard of care + c
Stx1/ c
Stx2 administered concomitantly at a dose of 1 mg/kg per antibody
Comparator arm: Standard of care + placebo.
After the Independent Data Monitoring Committee (IDMC) review, the last 21 patients
Stx2 administered concomitantly at a dose of 3 mg/kg per antibody
Comparator arm: Standard of care + placebo.
Study medication vials will be blinded between c
Stx2 and placebo. Each vial contains a volume of 2ml of aqueous sterile solution for injection at a concentration of 10mg / ml. It will be given in a single dose diluted in normal saline by slow intra
Sponsors
Thallion Pharmaceuticals, Inc,
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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.
Countries
Argentina, Chile, Peru
Contacts
Public ContactMarcela Toledo
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed