BEFORE: Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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 |
Outcome Measures
Primary Outcome Measures
- Recurrence rate [Wee 8]
% of patients who, having presented cure of the episode of ICD, develop recurrence of ICD after the treatment of the first episode.
- Recurrence rate [Week 24]
% of patients who, having presented cure of the episode of ICD, develop recurrence of ICD after the treatment of the first episode.
- 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 [Throughout the study until 24 weeks after the diagnosis of ICD]
Total days of hospitalization of patients
- 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 [2 hours (1 hour during the infusion and 1 hour post infusion)]
Rate of adverse events. Sampson criteria will be used to define anaphylaxis will be used
- Rate of cardiological safety events. [Throughout the study completion, an average of 26 weeks]
Episodes of acute coronary síndrome, arrhythmia, heart failure Will be recorded
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who have granted the IC and who are going to comply with the study visits and procedures according to their life expectations.
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Patient ≥ 18 years of age
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Having a first episode of DCI and presenting an estimated recurrence risk greater than 35%.
Exclusion Criteria:
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Patients <18 years old
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Pregnant or lactating women
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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.
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Life expectancy less than 6 months
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Impossibility or serious difficulties of clinical follow-up
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Any digestive disease that, at the discretion of the researcher, makes it difficult to assess the response due to impaired bowel habits.
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Immunoglobulin treatment in the last 3 months
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Previous treatment with Bezlotoxumab
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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.
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Anti- ICD treatment forecast for more than 14 days (eg vancomycin in descending pattern) for the current episode.
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Health center staff
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Direct family members of the research team
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clinico San Carlos | Madrid | Spain | ||
| 2 | Hospital Fundacion de Alcorcón | Madrid | Spain | ||
| 3 | Hospital Gregorio Marañon | Madrid | Spain | ||
| 4 | Hospital Ramón y Cajal | Madrid | Spain | ||
| 5 | Hospital Univ. La Paz | Madrid | Spain | ||
| 6 | Hospital Univ. Puerta de HIerro | Madrid | Spain |
Sponsors and Collaborators
- Fundacion SEIMC-GESIDA
- Merck Sharp & Dohme LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GEIRAS-GIH 0118
- SEI-BEZ-2018-01