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.
Study Type
OBSERVATIONAL
Enrollment
869
Treatment with bezlotoxumad according to the routine clinical practices
Hospital Clinico San Carlos
Madrid, Spain
Hospital Fundacion de Alcorcón
Madrid, Spain
Hospital Gregorio Marañon
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Recurrence rate
% of patients who, having presented cure of the episode of ICD, develop recurrence of ICD after the treatment of the first episode.
Time frame: 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.
Time frame: Week 24
Rate of healing of the ICD episode defined as absence of diarrhea within 48 hours after the end of the episode treatment.
Time frame: 48 hours after the end of the episode treatment
Hospital stays
Total days of hospitalization of patients
Time frame: Throughout the study until 24 weeks after the diagnosis of ICD
Percentage of readmissions due to ICD
Time frame: 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
Time frame: 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
Time frame: Throughout the study completion, an average of 26 weeks
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Hospital Univ. La Paz
Madrid, Spain
Hospital Univ. Puerta de HIerro
Madrid, Spain