Clinical trial NCT04075422: Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.
Official title: Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence. BEFORE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clostridium Difficile Infection
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-08-30
Enrollment: 869
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective cohort: patient with a high risk of recurrence during the first episode of Clostridium difficile infection.

Retrospective cohort: all the patients diagnostic of the first episode of clostridium in the previous year and meet the inclusión/exclusión criteria

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence rate
timeFrame: Wee 8
measure: Recurrence rate
timeFrame: Week 24
measure: Rate of healing of the ICD episode defined as absence of diarrhea within 48 hours after the end of the episode treatment.
timeFrame: 48 hours after the end of the episode treatment
measure: Hospital stays
timeFrame: Throughout the study until 24 weeks after the diagnosis of ICD
measure: Percentage of readmissions due to ICD
timeFrame: From the 'Treatment visit' up to week 24 post -treatment visit ( an average of 24 weeks)
measure: Adverse events related with the infusion
timeFrame: 2 hours (1 hour during the infusion and 1 hour post infusion)
measure: Rate of cardiological safety events.
timeFrame: Throughout the study completion, an average of 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Fundacion de Alcorcón
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Univ. La Paz
city: Madrid
country: Spain
facility: Hospital Univ. Puerta de HIerro
Study officials:
References: