EICHORCondition: Hemolytic Uremic Syndrome of Childhood · Sponsor: University Hospital, Toulouse
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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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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 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)
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| University Hospital | Amiens, France | — |
| University Hospital | Angers, France | — |
| University Hospital | Besançon, France | — |
| Pellegrin Hospital | Bordeaux, France | — |
| Morvan Hospital | Brest, France | — |
| University Hospital | Grenoble, France | — |
| Jeanne de Flandre Hospital | Lille, France | — |
| Mother and Child Hospital | Limoges, France | — |
| Women, Mother and Child Hospital | Lyon, France | — |
| La Timone Hospital | Marseille, France | — |
| University Hospital | Montpellier, France | — |
| Mother and Child Hospital | Nantes, France | — |
+ 6 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT02205541