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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

869 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-10-28

Brief Summary

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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.

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Detailed Description

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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

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Clostridium Difficile Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Prospective cohort

64 patients treated with Bezlotoxumab

Bezlotoxumab Injection [Zinplava]

Intervention Type DRUG

Treatment with bezlotoxumad according to the routine clinical practices

Retrospective Cohort (Control)

All the first episodes diagnosed in each participating sites during the previous year that meet the inclusion criteria

No interventions assigned to this group

Interventions

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Bezlotoxumab Injection [Zinplava]

Treatment with bezlotoxumad according to the routine clinical practices

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who have granted the IC and who are going to comply with the study visits and procedures according to their life expectations.
* Patient ≥ 18 years of age
* Having a first episode of DCI and presenting an estimated recurrence risk greater than 35%.

Exclusion Criteria

* Patients \<18 years old
* Pregnant or lactating women
* Women of childbearing age who are not willing to use an appropriate contraceptive method (such as oral contraceptives, intrauterine device or contraceptive barrier method along with spermicide or surgical sterilization) during the study.
* Life expectancy less than 6 months
* Impossibility or serious difficulties of clinical follow-up
* Any digestive disease that, at the discretion of the researcher, makes it difficult to assess the response due to impaired bowel habits.
* Immunoglobulin treatment in the last 3 months
* Previous treatment with Bezlotoxumab
* Treatment with an experimental drug in the previous 30 days or participating or planning to participate in any other clinical trial with an experimental drug during the 12-week trial period.
* Anti- ICD treatment forecast for more than 14 days (eg vancomycin in descending pattern) for the current episode.
* Health center staff
* Direct family members of the research team

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No