NCT04075422

Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.

Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence. BEFORE Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 869 (actual)
• Sponsor: Fundacion SEIMC-GESIDA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The main hypothesis of the study is that Bezlotoxumab is well tolerated and effective in reducing the recurrence of ICD (Clostridium Difficile infection) in patients with a high risk of recurrence in the first episode of ICD. As a consequence, the number of readmissions and hospital stays, will be reduced in patients treated with Bezlotoxumab.

Detailed description

This is a comparative study of patients with a high risk of recurrence of ICD in the first episode, treated with Bezlotoxumab (together with standard ICD therapy), with patients with first episode of ICD from a paired retrospective cohort (1: 2) using a propensity score.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
DRUG	Bezlotoxumab Injection [Zinplava]	Treatment with bezlotoxumad according to the routine clinical practices

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-08-05
• Completion: 2022-10-28
• First posted: 2019-08-30
• Last updated: 2023-06-26

Locations

6 sites across 1 country: Spain