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| ID | Type | Description | Link |
|---|---|---|---|
| SEI-BEZ-2018-01 | Other Identifier | AEMPS |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bezlotoxumab Injection [Zinplava] | Drug | Treatment with bezlotoxumad according to the routine clinical practices |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico San Carlos | Madrid | Spain | ||||
| Hospital Fundacion de Alcorcón |
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| 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 |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000613978 | bezlotoxumab |
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