NCT01252199

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2010

Geographic Reach
3 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 2, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

April 25, 2013

Status Verified

April 1, 2013

Enrollment Period

2.1 years

First QC Date

November 29, 2010

Last Update Submit

April 23, 2013

Conditions

Shiga Toxin Producing Bacterial Infection

Keywords

ShigamabsMonoclonalAntibodiesShigaToxinE.coliHUSBloodyDiarrhea

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 1 year

Secondary Outcomes (1)

  • 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.

    Up to 1 year

Study Arms (2)

cαStx1/cαStx2

EXPERIMENTAL
Drug: cαStx1/cαStx2

Control

PLACEBO COMPARATOR
Drug: Placebo

Interventions

cαStx1/cαStx2DRUG

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

cαStx1/cαStx2
PlaceboDRUG

Placebo administered over 1 hour + standard of care

Control

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Bahía Blanca, Argentina

Location

Unknown Facility

Buenos Aires, Argentina

Location

Unknown Facility

Córdoba, Argentina

Location

Unknown Facility

La Plata, Argentina

Location

Unknown Facility

Mendoza, Argentina

Location

Unknown Facility

Paraná, Argentina

Location

Unknown Facility

San Miguel de Tucumán, Argentina

Location

Unknown Facility

Concepción, Chile

Location

Unknown Facility

Santiago, Chile

Location

Unknown Facility

Valparaíso, Chile

Location

Unknown Facility

Lima, Peru

Location

Related Publications (2)

  • Imdad A, Nelson JR, Tanner-Smith EE, Huang D, Gomez-Duarte OG. Interventions for preventing diarrhoea-associated haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2025 Apr 25;4(4):CD012997. doi: 10.1002/14651858.CD012997.pub3.

    PMID: 40277027DERIVED

  • 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.

    PMID: 34219224DERIVED

MeSH Terms

Conditions

Escherichia coli InfectionsDiarrhea

Condition Hierarchy (Ancestors)

Enterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2010

First Posted

December 2, 2010

Study Start

November 1, 2010

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

April 25, 2013

Record last verified: 2013-04

Locations

PE(1)AR(7)CL(3)