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

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

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.

Study Overview

• Status: Completed
• Conditions: Clostridium Difficile Infection
• Intervention / Treatment: Drug: Bezlotoxumab Injection [Zinplava]

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.

• Study Type: Observational
• Enrollment (Actual): 869

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Hospital Ramón y Cajal
  • Madrid, Spain
    • Hospital Gregorio Marañón
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • Madrid, Spain
    • Hospital Univ. La Paz
  • Madrid, Spain
    • Hospital Fundación de Alcorcón
  • Madrid, Spain
    • Hospital Univ. Puerta de Hierro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective cohort; 64 patients treated with Bezlotoxumab	Drug: Bezlotoxumab Injection [Zinplava]; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate	% of patients who, having presented cure of the episode of ICD, develop recurrence of ICD after the treatment of the first episode.	Wee 8
Recurrence rate	% of patients who, having presented cure of the episode of ICD, develop recurrence of ICD after the treatment of the first episode.	Week 24
Rate of healing of the ICD episode defined as absence of diarrhea within 48 hours after the end of the episode treatment.		48 hours after the end of the episode treatment
Hospital stays	Total days of hospitalization of patients	Throughout the study until 24 weeks after the diagnosis of ICD
Percentage of readmissions due to ICD		From the 'Treatment visit' up to week 24 post -treatment visit ( an average of 24 weeks)
Adverse events related with the infusion	Rate of adverse events. Sampson criteria will be used to define anaphylaxis will be used	2 hours (1 hour during the infusion and 1 hour post infusion)
Rate of cardiological safety events.	Episodes of acute coronary síndrome, arrhythmia, heart failure Will be recorded	Throughout the study completion, an average of 26 weeks

Collaborators and Investigators

• Sponsor: Fundacion SEIMC-GESIDA
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): August 5, 2021
• Study Completion (Actual): October 28, 2022

Study Registration Dates

• First Submitted: August 27, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Recurrence; Clostridium Infections
• Other Study ID Numbers: GEIRAS-GIH 0118; SEI-BEZ-2018-01 (Other Identifier: AEMPS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No