drugset / Trial / NCT01252199
Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 and 2
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2010-11
- Primary completion
- 2012-12
- Completion
- 2013-02
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
paper However, no firm conclusions about the efficacy of these interventions can be drawn given the small number of included studies and the small sample sizes of those included studies. PMID 34219224 ↗
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | cαStx1 | Unknown | 1 mg/kg | — |
| Subject | cαStx1 | Unknown | 3 mg/kg | — |
| Subject | cαStx2 | Unknown | 1 mg/kg | — |
| Subject | cαStx2 | Unknown | 3 mg/kg | — |