Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated
Brief Summary: OBJECTIVES: I. Determine the effect of SYNSORB Pk therapy on mortality and frequency of severe extrarenal complications observed in children with acute stage E. coli-associated hemolytic uremic syndrome.

II. Determine the effect of SYNSORB Pk therapy on the need for the duration of dialysis in these patients.

III. Determine the effect of SYNSORB Pk therapy on the recovery of renal function and resolution of urinary abnormalities in these patients.


Options:
A: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Clinically diagnosed E. coli-associated diarrhea-associated hemolytic uremic syndrome (HUS)
* Diarrheal prodrome within 7 days before onset of disease
* No HUS associated with the following: Hereditary Post-bone marrow transplantation Streptococcus pneumoniae infection
* No prior catastrophic complications

--Patient Characteristics--

* Hematopoietic: Thrombocytopenia less than 140,000/mm3 Fragmented red blood cells
* Renal: Renal involvement (hematuria, proteinuria, or azotemia) No underlying glomerular disease
* Other: HIV negative No pre-existing structural abnormality or dysmotility syndrome of the gastrointestinal tract No inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
B: Inclusion Criteria:

1. Bloody diarrhea (by visual inspection) for no more than 36 hours prior to screening (signature of the informed consent).
2. Detection of Shiga toxin (Stx1 and/or Stx2) in stool

Exclusion Criteria:

1. Laboratory findings compatible with development of at least two out of three following criteria that define Hemolytic Uremic Syndrome (HUS):

   Hemolytic Anemia: hematocrit \< 30% with evidence of hemolysis (as indicated by Lactate Dehydrogenase (LDH) above the upper limit of normal for age or the finding of schistocytes on peripheral smear); Thrombocytopenia: platelet count \<150 x 103/uL; Nephropathy: serum creatinine \> Upper Limit Normal (ULN) adjusted for age and gender.
2. Bloody-diarrhea suspected not to be caused by Shiga Toxin-Producing Bacteria (STPB) but by other organisms or preexisting diseases.
3. Family history of proven or suspected hereditary Hemolytic Uremic Syndrome (HUS) or thrombotic thrombocytopenic purpura (TTP).
4. History of chronic/recurrent hemolytic anemia or thrombocytopenia.
C: Inclusion Criteria:

1. Age \<18.0 years;
2. STEC infection \[positive culture OR antigen OR polymerase chain reaction test for Stx/gene\];
3. Day of illness 1-10: Children who develop HUS will do so by day #14 of illness;8 restricting enrolment to the first 10 days will ensure all participants are at risk of HUS.

Exclusion Criteria:

1. Evidence of evolving HUS: A) Hematocrit \<30% OR B) Platelet count \<150 x 109/L;
2. Responsible physician desires patient admission (therefore unable to randomize);
3. Unable to contact family within 48 hours of positive stool test;
4. Patient with history of atypical HUS;
5. Chronic disease limiting fluid volumes administered (e.g. impaired cardiac function)
D: Inclusion Criteria:

1. Age of ≥ 1 to \< 10 y.
2. Signed informed consent from the parent(s)/legal guardian with assent from the subject as appropriate by age and regulatory guidance.
3. Bloody diarrhea based upon history or presentation (by visual inspection).
4. Detection of Stx2 in stool based on enzyme immunoassay (EIA) and/or stx2 based on PCR before randomization.

   NOTE: The basis for accepting a positive test for stx2 by EIA is based on taking as valid the results yielded from an EIA whose sensitivity and specificity are greater than 98.7% and 100%, respectively (according to the description in the insert) as per recommendation given by the NRL. The Sponsor will select the investigational sites that have in their laboratory such EIA test used in the STEC diagnostic routine algorithm. (Appendix 6).
5. For children between 1 to 5 years old: weight for length/height between percentiles 3 (\< 2 z score) and 97 (\> 2 z score) corresponding to age (according to the reference tables "WHO Child Growth Standards".
6. For children ≥ 5 years: Body mass index (BMI) between percentiles 3 (\<2 z score) and 97 (\> 2 z score) corresponding to age (according to the reference tables "WHO Child Standards, Appendix 4)

Exclusion Criteria:

1. Any laboratory findings compatible with the development of HUS:

   * Microangiopathic hemolytic anemia defined as LDH above the ULN for age with the finding of schistocytes on peripheral smear and a negative Coomb's test, and/or
   * Thrombocytopenia: platelet count \< 150 × 103/μL, and/or
   * Renal failure: serum creatinine \> ULN adjusted for age and gender criteria despite correction of hypovolemia, and/or hematuria, and/or proteinuria (Table 7.1)11 NOTE: Laboratory results must be obtained within 24 h before the 1st study drug administration; there must be no clinical signs and symptoms of HUS at the time laboratory assessments are obtained. If there is any change in clinical presentation in the 24 h before the 1st study drug administration, laboratory assessments are to be repeated and results reviewed before study drug administration.

   NOTE: Laboratory and physical examination results must indicate normal hydration before the 1st study drug administration.
2. A history of chronic/recurrent hemolytic anemia, thrombocytopenia, or chronic renal failure.
3. A family history of aHUS.
4. Anuria or oliguria after hypovolemia is corrected.
5. Evidence of clinically significant chronic active disease not medically controlled.
6. History of anaphylaxis, prior administration of equine serum (eg, antitetanus serum or anti-ophidic serum, or anti-arachnid toxin serum), or allergic reaction to contact with, or exposure to, horses.
7. Family relation or work relation with a member of the personnel of the research group.

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Answer: A