A Phase II Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 (cαStx1) and 2 (cαStx2) Administered Concomitantly to Children With Shiga Toxin-Producing Bacterial (STPB) Infection and Bloody Diarrhea (SHIGATEC Trial)

CompletadoFase 2ClinicalTrials.gov

ID: NCT01252199Tipo: INTERVENTIONALInicio: 1 de nov de 2010Fin estimado: 1 de feb de 2013

Traducción no disponible, mostrando original

Resumen

This study is designed to evaluate the safety and efficacy of cαStx1 and cαStx2 administered concomitantly in children presenting early signs of Shiga Toxin-Producing Bacterial (STPB) Infection.

Descripción detallada

Currently, there is no etiological treatment of STPB-induced HUS. Ideally, such treatment would be started in the early phase of the infection and would protect against both types of toxins and all of their variants. The chimeric anti-Shiga toxins 1 (cαStx1) and 2 (cαStx2) antibodies are intended to be administered as a single infusion and provide simultaneous protection against the two Shiga toxins (Stx1 and Stx2) by decreasing the incidence and severity of Shiga toxin-mediated clinical events including bloody diarrhea/hemorrhagic colitis and Hemolytic Uremic Syndrome (HUS) and associated sequelae.

Elegibilidad

Edad mínima: 6 MonthsEdad máxima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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.
Bloody-diarrhea suspected not to be caused by Shiga Toxin-Producing Bacteria (STPB) but by other organisms or preexisting diseases.
Family history of proven or suspected hereditary Hemolytic Uremic Syndrome (HUS) or thrombotic thrombocytopenic purpura (TTP).
History of chronic/recurrent hemolytic anemia or thrombocytopenia.

Intervenciones

drug

cαStx1/cαStx2

cαStx1/cαStx2 administered concomitantly at a dose of 1 mg/kg (low dose cohort) or 3 mg/kg (high dose cohort)per antibody over 1 hour + standard of care

drug

Placebo

Placebo administered over 1 hour + standard of care

Ubicaciones

Bahía Blanca, Argentina

Buenos Aires, Argentina

Córdoba, Argentina

La Plata, Argentina

Mendoza, Argentina

Paraná, Argentina

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalThallion Pharmaceuticals

ColaboradorLFB Biotechnologies, SAS

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