Clostridium DifficilePhase 4NCT03937999
Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.
A Phase 4 study testing Bezlotoxumab in people with Clostridium Difficile, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This study will examine whether the human monoclonal antibody, bezlotoxumab administered AFTER acute Clostridioides difficile (C.diff) has resolved, but during a period of subsequent antibiotic therapy, will eliminate the high risk of C. diff relapse. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- Bezlotoxumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2019to 15 May 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- C diff diagnosed within 90 days
- Receipt of high-risk antibiotics for C diff (e.g. Beta-lactams, carbapenems) in an inpatient setting
- Age 60 years and older
Who cannot join
- Receipt of current C.diff active antibiotics (oral vancomycin, fidaxomycin, metronidazole, tigecycline/ doxycycline, nitazoxanide, rifamycin) within 72hrs.
- Not Expected to survive 8 weeks
- Prior or planned fecal microbiota transplant or Bezlotoxumab use
- Congestive heart failure (a potential risk of Bezlotoxumab)
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Pragmatic Trial of Secondary Prophylaxis With Bezlotoxumab to Prevent C. Difficile Relapse Among Hospitalized Adults Receiving Antibiotics.
This study will examine whether the human monoclonal antibody, bezlotoxumab administered AFTER acute Clostridioides difficile (C.diff) has resolved, but during a period of subsequent antibiotic therapy, will eliminate the high risk of C. diff relapse.
Read the detailed description
Clostridioides difficile (C. diff) is a germ (bacteria) that causes life-threatening diarrhea. It is usually a side-effect of taking antibiotics that affect the normal balance of bacteria in the intestines. When the "good bacteria" in the intestine are killed by antibiotics, the C.diff bacteria begin to grow and produce toxins, causing frequent diarrhea and other symptoms such as abdominal pain or tenderness, loss of appetite, low-grade fever, nausea and vomiting. C. diff can be treated by using special antibiotics, but it tends to come back in about 20% of patients. C-diff is problematic because of frequent relapses after apparent cure. The greatest risk factor for relapse is receipt of subsequent antibiotics, in the hospital, shortly after being treated.
Zinplava™(bezlotoxumab) is an FDA approved human monoclonal antibody designed to prevent the recurrence of C.diff.This is not an antibiotic, as it does not kill C. diff, but is an antibody to C. diff toxins, which stops the damage. When Bezlotoxumab is given during a C. diff infection together with antibiotics to kill C. diff, it decreases the risk that C. diff will come back by about one-half. Bezlotoxumab is approved for use when given during a C. diff infection, but it has not been used to prevent C diff in other situations, such as the one being studied in this research.
- Conditions
- Clostridium Difficile
- Being tested
- Bezlotoxumab
- Keywords
- clostridium difficile, diarrhea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BezlotoxumabDrug
Also called Zinplava
Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial.
| Study group | Role | What they receive |
|---|---|---|
| Bezlotoxumab Arm | Experimental | Single dose of Bezlotoxumab 10mg/kg iv over 60 minutes on Day 0 Receives: Drug: Bezlotoxumab |
| No Bezlotoxumab | No intervention | Control group who are eligible as per the inclusion/exclusion criteria to the Bezlotoxumab arm, but not given Bezlotoxumab (Day 0) . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of C.Difficile Infection
Measured: within 4 weeks
Secondary outcomes (3)
Recurrence of C.Difficile Infection
Measured: within 8 weeks
Rate of Deaths
Measured: within 8 weeks
Relapse of C. Difficile by 8 Weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start30 Aug 2019
- Primary completion15 May 2022
- Study completion15 May 2022
Why it stopped: Slow enrollment due to COVID19 , change in practice with standardized use of oral vancomycin prophylaxis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clostridium DifficileStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group compared to concurrent and historical control groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Paul Riska, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937999
- Sponsor's protocol ID
- 2019-10212
- Other IDs
- 2019
- Status last verified
- Oct 2022
- First submitted
- 2 May 2019
- Last updated
- 9 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Trial of Secondary Prophylaxis With Bezlotoxumab to Prevent C. Difficile Relapse Among Hospitalized Adults Receiving Antibiotics.
- ClinicalTrials.gov ID
- NCT03937999
- Acronym / sponsor ID
- 2019-10212
- Conditions
- Clostridium Difficile
- Keywords
- clostridium difficile, diarrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment due to COVID19 , change in practice with standardized use of oral vancomycin prophylaxis
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Posted 9 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine whether the human monoclonal antibody, bezlotoxumab administered AFTER acute Clostridioides difficile (C.diff) has resolved, but during a period of subsequent antibiotic therapy, will eliminate the high risk of C. diff relapse.
Detailed description
Clostridioides difficile (C. diff) is a germ (bacteria) that causes life-threatening diarrhea. It is usually a side-effect of taking antibiotics that affect the normal balance of bacteria in the intestines. When the "good bacteria" in the intestine are killed by antibiotics, the C.diff bacteria begin to grow and produce toxins, causing frequent diarrhea and other symptoms such as abdominal pain or tenderness, loss of appetite, low-grade fever, nausea and vomiting. C. diff can be treated by using special antibiotics, but it tends to come back in about 20% of patients. C-diff is problematic because of frequent relapses after apparent cure. The greatest risk factor for relapse is receipt of subsequent antibiotics, in the hospital, shortly after being treated.
Zinplava™(bezlotoxumab) is an FDA approved human monoclonal antibody designed to prevent the recurrence of C.diff.This is not an antibiotic, as it does not kill C. diff, but is an antibody to C. diff toxins, which stops the damage. When Bezlotoxumab is given during a C. diff infection together with antibiotics to kill C. diff, it decreases the risk that C. diff will come back by about one-half. Bezlotoxumab is approved for use when given during a C. diff infection, but it has not been used to prevent C diff in other situations, such as the one being studied in this research.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group compared to concurrent and historical control groups
| Arm | Type | Receives |
|---|---|---|
| Bezlotoxumab Arm | Experimental | Drug: BezlotoxumabSingle dose of Bezlotoxumab 10mg/kg iv over 60 minutes on Day 0 |
| No Bezlotoxumab | No intervention | –Control group who are eligible as per the inclusion/exclusion criteria to the Bezlotoxumab arm, but not given Bezlotoxumab (Day 0) . |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- C diff diagnosed within 90 days
- Receipt of high-risk antibiotics for C diff (e.g. Beta-lactams, carbapenems) in an inpatient setting
- Age 60 years and older
Key exclusion criteria (4 listed)
- Receipt of current C.diff active antibiotics (oral vancomycin, fidaxomycin, metronidazole, tigecycline/ doxycycline, nitazoxanide, rifamycin) within 72hrs.
- Not Expected to survive 8 weeks
- Prior or planned fecal microbiota transplant or Bezlotoxumab use
- Congestive heart failure (a potential risk of Bezlotoxumab)
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 |
|---|---|---|
| BezlotoxumabAlso: ZinplavaInjection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial. | Drug | Bezlotoxumab Arm |
Primary outcome
Recurrence of C.Difficile Infection
Time frame: within 4 weeks
3 secondary outcomes
Recurrence of C.Difficile Infection
Time frame: within 8 weeks
Rate of Deaths
Time frame: within 8 weeks
Relapse of C. Difficile by 8 Weeks
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Clostridium Difficile
Not yet recruitingObservational study
Epidemiology of Clostridioides Difficile Infection (CDI) in Long-term Care Facilities, Assessment of Professional Practices Related to CDI Risk Prevention, and Strategies for Improving Care.
Clostridioides Difficile Infection
Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
RecruitingPhase 3
A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older
Clostridoides Difficile Associated Disease
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
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.
Paul Riska, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bezlotoxumab in people with Clostridium Difficile, run by Montefiore Medical Center at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of C.Difficile Infection (time frame: within 4 weeks). 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 9 Nov 2022.