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

Fundacion SEIMC-GESIDA

Status

Completed

Conditions

Clostridium Difficile Infection

Treatments

Drug: Bezlotoxumab Injection [Zinplava]

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04075422

SEI-BEZ-2018-01 (Other Identifier)

GEIRAS-GIH 0118

Details and patient eligibility

About

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.

Full 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.

Enrollment

869 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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