Eculizumab in Shiga-toxin Related Hemolytic and Uremic Syndrome Pediatric Patients - ECULISHU (NCT02205541) | Clinical Trial Compass
CompletedPhase 3
Eculizumab in Shiga-toxin Related Hemolytic and Uremic Syndrome Pediatric Patients - ECULISHU
France100 participantsStarted 2015-06
Plain-language 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 potentially devastating disease.
Furthermore, published data concerning the use of ECZ in STEC-HUS are controversial, reflecting statistical bias in retrospective or uncontrolled studies, thus emphasizing the need for prospective studies.
Who can participate
Age range1 Month – 18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 rhy…
What they're measuring
1
the duration in days of extrarenal epuration
Timeframe: From the inclusion date and assessed up to 13 months