Status:
COMPLETED
Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 and 2
Lead Sponsor:
Thallion Pharmaceuticals
Collaborating Sponsors:
LFB Biotechnologies, SAS
Conditions:
Shiga Toxin Producing Bacterial Infection
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
Brief 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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01252199
Start Date
November 1 2010
End Date
February 1 2013
Last Update
April 25 2013
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Bahía Blanca, Argentina
2
Buenos Aires, Argentina
3
Córdoba, Argentina
4
La Plata, Argentina