Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.
BEFORE
2 other identifiers
observational
869
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2019
CompletedFirst Posted
Study publicly available on registry
August 30, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2022
CompletedJune 26, 2023
June 1, 2023
1.8 years
August 27, 2019
June 23, 2023
Conditions
Outcome Measures
Primary Outcomes (7)
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
Study Arms (2)
Prospective cohort
64 patients treated with Bezlotoxumab
Retrospective Cohort (Control)
All the first episodes diagnosed in each participating sites during the previous year that meet the inclusion criteria
Interventions
Treatment with bezlotoxumad according to the routine clinical practices
Eligibility Criteria
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
You may qualify if:
- 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%.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundacion SEIMC-GESIDAlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (6)
Hospital Clinico San Carlos
Madrid, Spain
Hospital Fundacion de Alcorcón
Madrid, Spain
Hospital Gregorio Marañon
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Univ. La Paz
Madrid, Spain
Hospital Univ. Puerta de HIerro
Madrid, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2019
First Posted
August 30, 2019
Study Start
October 1, 2019
Primary Completion
August 5, 2021
Study Completion
October 28, 2022
Last Updated
June 26, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share