CompletedPhase 2

Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 and 2

Argentina45 participantsStarted 2010-11

Plain-language summary

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.

Who can participate

Age range6 Months – 18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. Laboratory findings compatible with development of at least two out of three following criteria that define Hemolytic Uremic Syndrome (HUS):
✕. 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.

What they're measuring

Safety and Tolerability: Evaluation of number and type of adverse events and serious adverse events between arms and dosage cohorts

Timeframe: Up to 1 year

Trial details

NCT IDNCT01252199

SponsorThallion Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-12

View on ClinicalTrials.gov More Shiga Toxin Producing Bacterial Infection trials