Clostridium Difficile InfectionBEFORENCT04075422
Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.
An observational study of Clostridium Difficile Infection, run by Fundacion SEIMC-GESIDA at 6 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Bezlotoxumab Injection [Zinplava]
- Type of treatment
- Injection or infusion
- How many people
- 869 participants
- Where
- 6 sitesSpain
- Study dates
- 1 Oct 2019to 28 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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
Who may be able to join
- 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%.
Who cannot join
- 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.
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Clinico San Carlos
Madrid
Hospital Fundacion de Alcorcón
Madrid
Hospital Gregorio Marañon
Madrid
Hospital Ramón y Cajal
Madrid
Hospital Univ. La Paz
Madrid
Hospital Univ. Puerta de HIerro
Madrid
About this study
Official title: Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence. BEFORE Study
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.
Read the 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 ICD from a paired retrospective cohort (1: 2) using a propensity score.
- Conditions
- Clostridium Difficile Infection
- Being tested
- Bezlotoxumab Injection [Zinplava]
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bezlotoxumab Injection [Zinplava]Drug
Treatment with bezlotoxumad according to the routine clinical practices
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | 64 patients treated with Bezlotoxumab Receives: Drug: Bezlotoxumab Injection [Zinplava] | |
| Retrospective Cohort (Control) | All the first episodes diagnosed in each participating sites during the previous year that meet the inclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
% of patients who, having presented cure of the episode of ICD, develop recurrence of ICD after the treatment of the first episode.
Measured: 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.
Measured: Week 24
Rate of healing of the ICD episode defined as absence of diarrhea within 48 hours after the end of the episode treatment.
Measured: 48 hours after the end of the episode treatment
Hospital stays
Total days of hospitalization of patients
Measured: Throughout the study until 24 weeks after the diagnosis of ICD
Percentage of readmissions due to ICD
Measured: 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
Measured: 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
Measured: Throughout the study completion, an average of 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start1 Oct 2019
- Primary completion5 Aug 2021
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 869 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075422
- Sponsor's protocol ID
- GEIRAS-GIH 0118
- Other IDs
- SEI-BEZ-2018-01
- Acronym
- BEFORE
- Status last verified
- Jun 2023
- First submitted
- 27 Aug 2019
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence. BEFORE Study
- ClinicalTrials.gov ID
- NCT04075422
- Acronym / sponsor ID
- BEFORE / GEIRAS-GIH 0118
- Conditions
- Clostridium Difficile Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 869 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 ICD from a paired retrospective cohort (1: 2) using a propensity score.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | Drug: Bezlotoxumab Injection [Zinplava]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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- 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%.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bezlotoxumab Injection [Zinplava]Treatment with bezlotoxumad according to the routine clinical practices | Drug | Prospective cohort |
Primary outcome
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.
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.
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
Time frame: Throughout the study until 24 weeks after the diagnosis of ICD
Total days of hospitalization of patients
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile Infection, run by Fundacion SEIMC-GESIDA at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: Wee 8). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.