Status:
COMPLETED
Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.
Lead Sponsor:
Fundacion SEIMC-GESIDA
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Clostridium Difficile Infection
Eligibility:
All Genders
18+ years
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 28 2022
Estimated Enrollment :
869 Patients enrolled
Trial Details
Trial ID
NCT04075422
Start Date
October 1 2019
End Date
October 28 2022
Last Update
June 26 2023
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
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