Back to resultsStudy of Chimeric Monoclonal Antibodies to Shiga Toxins 1 and 2
Primary Purpose
Shiga Toxin Producing Bacterial Infection
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cαStx1/cαStx2
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Shiga Toxin Producing Bacterial Infection focused on measuring Shigamabs, Monoclonal, Antibodies, Shiga, Toxin, E.coli, HUS, Bloody, Diarrhea
Eligibility Criteria
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):
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
cαStx1/cαStx2
Control
Arm Description
Outcomes
Primary Outcome Measures
Safety and Tolerability: Evaluation of number and type of adverse events and serious adverse events between arms and dosage cohorts
Evaluation of the safety and tolerability of two different intravenous dose levels of a combined cαStx1/cαStx2 preparation in separate groups of children presenting with Shiga Toxin-Producing Bacterial (STPB) infection.
Secondary Outcome Measures
Efficacy: Comparison of clinical event rates (Hemolytic Uremic Syndrome, Bloody Diarrhea) and associated sequelae between arms and dosage cohorts in children presenting with Shiga Toxin-Producing Bacterial (STPB) infection.
Full Information
NCT ID
NCT01252199
First Posted
November 29, 2010
Last Updated
April 23, 2013
Sponsor
Thallion Pharmaceuticals
Collaborators
LFB Biotechnologies, SAS
1. Study Identification
Unique Protocol Identification Number
NCT01252199
Brief Title
Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 and 2
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thallion Pharmaceuticals
Collaborators
LFB Biotechnologies, SAS
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shiga Toxin Producing Bacterial Infection
Keywords
Shigamabs, Monoclonal, Antibodies, Shiga, Toxin, E.coli, HUS, Bloody, Diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cαStx1/cαStx2
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
cαStx1/cαStx2
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered over 1 hour + standard of care
Primary Outcome Measure Information:
Title
Safety and Tolerability: Evaluation of number and type of adverse events and serious adverse events between arms and dosage cohorts
Description
Evaluation of the safety and tolerability of two different intravenous dose levels of a combined cαStx1/cαStx2 preparation in separate groups of children presenting with Shiga Toxin-Producing Bacterial (STPB) infection.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Efficacy: Comparison of clinical event rates (Hemolytic Uremic Syndrome, Bloody Diarrhea) and associated sequelae between arms and dosage cohorts in children presenting with Shiga Toxin-Producing Bacterial (STPB) infection.
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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):
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.
Facility Information:
City
Bahia Blanca
Country
Argentina
City
Buenos Aires
Country
Argentina
City
Cordoba
Country
Argentina
City
La Plata
Country
Argentina
City
Mendoza
Country
Argentina
City
Parana
Country
Argentina
City
Tucuman
Country
Argentina
City
Concepcion
Country
Chile
City
Santiago
Country
Chile
City
Valparaiso
Country
Chile
City
Lima
Country
Peru
12. IPD Sharing Statement
Citations:
PubMed Identifier
34219224
Citation
Imdad A, Mackoff SP, Urciuoli DM, Syed T, Tanner-Smith EE, Huang D, Gomez-Duarte OG. Interventions for preventing diarrhoea-associated haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Jul 5;7(7):CD012997. doi: 10.1002/14651858.CD012997.pub2.
Results Reference
derived
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Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 and 2
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