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OpenTrials
Completed

NCT Number: NCT04075422

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

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.

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Key information

Conditions

Clostridium Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clinico San Carlos, Madrid, Spain

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bezlotoxumab Injection [Zinplava]

Drug

Treatment with bezlotoxumad according to the routine clinical practices

Primary outcomes

  1. Recurrence rate

    Time frame: Wee 8

    % of patients who, having presented cure of the episode of ICD, develop recurrence of ICD after the treatment of the first episode.

  2. Recurrence rate

    Time frame: Week 24

    % of patients who, having presented cure of the episode of ICD, develop recurrence of ICD after the treatment of the first episode.

  3. 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

  4. Hospital stays

    Time frame: Throughout the study until 24 weeks after the diagnosis of ICD

    Total days of hospitalization of patients

  5. Percentage of readmissions due to ICD

    Time frame: From the 'Treatment visit' up to week 24 post -treatment visit ( an average of 24 weeks)

  6. Adverse events related with the infusion

    Time frame: 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

  7. Rate of cardiological safety events.

    Time frame: Throughout the study completion, an average of 26 weeks

    Episodes of acute coronary síndrome, arrhythmia, heart failure Will be recorded

Sponsors and collaborators

Lead sponsor

Fundacion SEIMC-GESIDA

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: BEFORE

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 30, 2019
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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