Status:
COMPLETED
Eculizumab in Shiga-toxin Related Hemolytic and Uremic Syndrome Pediatric Patients - ECULISHU
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Hemolytic Uremic Syndrome of Childhood
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief Summary
The investigators aim to perform the first controlled randomized prospective study using ECZ in pediatric STEC-HUS. This is of great interest as there is still no efficient specific therapy in that po...
Detailed Description
Hemolytic and uremic syndrome (HUS), characterized by thrombocytopenia, hemolytic anemia and acute renal failure (ARF), mainly affects children younger than 5 years old. Shiga-toxin (Stx) related HUS ...
Eligibility Criteria
Inclusion
- Pediatric patient (1 month-18 years old)
- Affected by STEC-HUS defined by :
- Thrombocytopenia (\<150 000/mm3)
- Mechanic hemolytic anemia (Hemoglobin \< 10g/dL, haptoglobin \<LLN, lactate dehydrogenase (LDH) \>upper limit of normal (ULN) and/or bilirubin \> ULN, presence of schizocytes)
- ARF defined by an estimated Schwartz 2009 creatinin clearance \<75ml/min/1,73m²
- With prodromal diarrhea and/or presence of an enterohemorrhagic strain of Escherichia Coli and/or identification of the Stx 1 or 2 genes in the stool sample or rectal swab
- Written consent of the 2 parents
- Female patients of childbearing potential must be practicing an effective, reliable and medically acceptable contraceptive regimen during the entire duration of the study and 5 months after the end of the participation.
Exclusion
- Neonatal HUS
- Malignancy
- Known HIV infection
- Pregnancy or lactation
- Identified drug exposure-related HUS
- Infection-related HUS
- Known systemic lupus erythematosus or antiphospholipid antibody positivity or syndrome
- Patient already enrolled in a drug trial
- Patient with ongoing meningococcal infection
- Patient affected by aHUS or family history of aHUS
- STEC-HUS patient with severe multiorgan involvement at diagnostic:
- Neurological involvement (seizures, coma, focal deficit) with signs of microangiopathy on cerebral Magnetic Resonance Imaging.
- Cardiac involvement (cardiac failure, ischemic myocarditis, conduction or rhythm troubles)
- Digestive involvement (severe pancreatitis defined by lipasemia\>500UI/L, severe hepatitis defined by transaminase \>x10ULN and/or prothrombin time\<60%, hemorrhagic colitis, bowel perforation, rectal prolapsus)
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02205541
Start Date
June 1 2015
End Date
June 1 2018
Last Update
July 12 2019
Active Locations (18)
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1
University Hospital
Amiens, France, 80054
2
University Hospital
Angers, France, 49100
3
University Hospital
Besançon, France, 25030
4
Pellegrin Hospital
Bordeaux, France, 33000