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

Clostridium Difficile Infection Clinical Trial

— BEFORE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04075422
• Other study ID #: GEIRAS-GIH 0118
• Secondary ID: SEI-BEZ-2018-01
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: October 28, 2022

Study information

• Verified date: June 2023
• Source: Fundacion SEIMC-GESIDA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 869
• Est. completion date: October 28, 2022
• Est. primary completion date: August 5, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Infections
• Recurrence

Intervention

Drug:
• Bezlotoxumab Injection [Zinplava]
Treatment with bezlotoxumad according to the routine clinical practices

Locations

Country	Name	City	State
Spain	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

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion SEIMC-GESIDA	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Hospital stays	Total days of hospitalization of patients	Throughout the study until 24 weeks after the diagnosis of ICD
Primary	Percentage of readmissions due to ICD		From the 'Treatment visit' up to week 24 post -treatment visit ( an average of 24 weeks)
Primary	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)
Primary	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