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Inclusion Criteria
Age ≥ 9 months and < 18 years at the time of randomization.
Only for subjects < 1 year and ≥ 15 years, confirmation of STEC infection.
Hospitalization at the participating institution.
History of onset of diarrhea within 10 days prior to the clinical diagnosis of STEC-HUS at the participating institution.
Clinical diagnosis of STEC-HUS defined as a subject with signs of renal damage, hemolysis and platelet consumption.
Informed consent form signed and dated by the subject or, the legal
guardian(s), with the subjects assent as appropriate based on age and regulatory guidelines of the region.
Negative pregnancy test.
Inclusion Criteria
History of onset of diarrhea within 10 days prior to the clinical diagnosis of STEC-HUS at the participating institution.
Clinical diagnosis of STEC-HUS defined as a subject with signs of renal damage, hemolysis and platelet consumption:
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Signs of renal damage defined as:
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Serum creatinine value above the normal upper limit for age and sex, and GFR below the normal lower limit for age and sex.
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Presence of hemolysis documented by:
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LDH levels above the normal upper limit for age, and/or.
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Presence of schistocytes in peripheral blood smear.
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Platelet consumption according to any of the following laboratory criteria:
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Peripheral blood platelet count < 150 × 103/μl, and/or.
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A decrease of more than 50% in peripheral blood platelet count compared to a sample collected within the previous 24 hours.
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Informed consent form signed and dated by the subject or, the legal guardian(s), with the subject's assent as appropriate based on age and regulatory guidelines of the region.
Subjects who have already had menarche must have a negative pregnancy test.
Exclusion Criteria
Start of dialysis within 48 hours prior to admission to the participating institution.
More than 24 hours from diagnosis of STEC-HUS at the participating institution up to randomization.
History of chronic/recurrent hemolytic anemia, thrombocytopenia, or CKD.
Personal and/or family history of atypical HUS.
Suspected HUS secondary to infectious processes other than gastrointestinal (e.g., Streptococcus pneumoniae, HIV).
Suspected HUS secondary to other etiologies (e.g., drug-associated HUS, neoplasms, bone marrow or solid organ transplantation, autoimmune disorders)
Any other acute or chronic medical condition that, in the opinion of the investigator, may interfere with the evaluation of the efficacy and/or safety of the study medication (such as acute infections, diabetes, liver disease requiring medical treatment, etc.)
Exclusion Criteria
Start of dialysis within 48 hours prior to admission to the participating institution.
More than 24 hours from diagnosis of STEC-HUS at the participating institution up to randomization.
History of chronic/recurrent hemolytic anemia, thrombocytopenia, or CKD.
Suspected HUS secondary to infectious processes other than gastrointestinal.
Suspected HUS secondary to other etiologies.
Any other acute or chronic medical condition that, in the opinion of the investigator, may interfere with the evaluation of the efficacy and/or safety of the study medication.
History of: (a) anaphylaxis of any kind; b) prior administration of equine serum.
Pregnant or breastfeeding woman.
Impossibility of hospitalization in the participating institution.
Concurrent participation in another clinical trial or having participated in a clinical trial in the last 3 months.
Severe malnutrition.
Medical conditions that may affect kidney function or cause/enhance neurological symptoms or signs.
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