Clostridium Difficile InfectionNCT04317963
Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection
An observational study of Clostridium Difficile Infection and Clostridium Difficile Infection Recurrence, run by University of Illinois Chicago at 1 site in United States.
Trial summary
This is a retrospective case:control study examining the use of adjunctive bezlotoxumab to standard C. difficile infection (CDI) treatment compared to standard CDI treatment alone in patients with CDI seen in an academic medical center's specialty outpatient clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection, Clostridium Difficile Infection Recurrence
- What is being tested?
- Bezlotoxumab and Standard CDI treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to 22 Feb 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients being treated for C. difficile infection
Who may be able to join
- Age 18 years and older
- Diagnosis of C. difficile infection by clinical signs and symptoms and/or C. difficile diagnostic assay
- Received bezlotoxumab in addition to standard CDI treatment
- Age 18 years and older
- Diagnosis of C. difficile infection by clinical signs and symptoms and/or C. difficile diagnostic assay
- Received only standard CDI treatment
Who cannot join
- Diarrhea due to causes other than C. difficile
- Incomplete documentation in the electronic medical record
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
This is a retrospective case:control study examining the use of adjunctive bezlotoxumab to standard C. difficile infection (CDI) treatment compared to standard CDI treatment alone in patients with CDI seen in an academic medical center's specialty outpatient clinic.
Read the detailed description
This specialty clinic is a unique practice setting where patients with ≥1 recurrent CDI and/or refractory disease are referred. The study will represent real-world data on the clinical use of bezlotoxumab as adjunctive therapy in combination with vancomycin or fidaxomicin for the treatment of patients with recurrent CDI. Retrospective chart review will be conducted for patients who visited the specialty CDI clinic between 1/1/2005 through 12/5/2019. Case patients will be defined as patients who have received bezlotoxumab 10 mg/kg intravenously in addition to standard CDI treatment. Controls will be defined as patients who have received only standard CDI treatment and will be enrolled in a 2:1 ratio to cases. The primary outcome is recurrence of CDI. Recurrence is defined as a new episode of C. difficile infection that occurs after the initial clinical cure of the baseline episode within 12 weeks of receipt of bezlotoxumab or standard CDI treatment. Clinical cure is defined as no diarrhea for 2 consecutive days after completion of standard-of-care CDI therapy. Recurrent CDI will be diagnosed via clinical signs and symptoms and CDI diagnostic assay.
- Being tested
- Bezlotoxumab, Standard CDI treatment
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BezlotoxumabBiological
Bezlotoxumab 10 mg/kg IV infusion in addition to standard CDI treatment
Standard CDI treatmentDrug
Standard CDI treatment includes one or a combination of oral vancomycin, oral vancomycin taper and/or pulse, fidaxomicin, and fidaxomicin taper and/or pulse
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients who have received bezlotoxumab 10 mg/kg intravenously in addition to standard CDI treatment. Receives: Biological: Bezlotoxumab | |
| Controls | Patients who have received only standard CDI treatment. Receives: Drug: Standard CDI treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of CDI Recurrence
New episode of C. difficile infection that occurs after initial clinical cure of the baseline episode within 12 weeks of receipt of bezlotoxumab or completion of standard CDI treatment.
Measured: within 12 weeks of receipt of bezlotoxumab
Secondary outcomes (1)
Clinical cure
Clinical cure is defined as no diarrhea for 2 consecutive days after completion of standard-of-care CDI therapy.
Measured: 2 consecutive days after completion of standard-of-care CDI therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start12 Feb 2020
- Primary completion22 Feb 2023
- Study completion22 Feb 2023
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.
- More trials run by University of Illinois ChicagoThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Eric R Wenzler, University of Illinois Chicago
- Investigators
- Eric R Wenzler, PharmD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317963
- Sponsor's protocol ID
- 2019-1381
- Status last verified
- Feb 2023
- First submitted
- 19 Mar 2020
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection
- ClinicalTrials.gov ID
- NCT04317963
- Acronym / sponsor ID
- 2019-1381
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 23 Mar 2020 (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.
This is a retrospective case:control study examining the use of adjunctive bezlotoxumab to standard C. difficile infection (CDI) treatment compared to standard CDI treatment alone in patients with CDI seen in an academic medical center's specialty outpatient clinic.
Detailed description
This specialty clinic is a unique practice setting where patients with ≥1 recurrent CDI and/or refractory disease are referred. The study will represent real-world data on the clinical use of bezlotoxumab as adjunctive therapy in combination with vancomycin or fidaxomicin for the treatment of patients with recurrent CDI. Retrospective chart review will be conducted for patients who visited the specialty CDI clinic between 1/1/2005 through 12/5/2019. Case patients will be defined as patients who have received bezlotoxumab 10 mg/kg intravenously in addition to standard CDI treatment. Controls will be defined as patients who have received only standard CDI treatment and will be enrolled in a 2:1 ratio to cases. The primary outcome is recurrence of CDI. Recurrence is defined as a new episode of C. difficile infection that occurs after the initial clinical cure of the baseline episode within 12 weeks of receipt of bezlotoxumab or standard CDI treatment. Clinical cure is defined as no diarrhea for 2 consecutive days after completion of standard-of-care CDI therapy. Recurrent CDI will be diagnosed via clinical signs and symptoms and CDI diagnostic assay.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Biological: BezlotoxumabPatients who have received bezlotoxumab 10 mg/kg intravenously in addition to standard CDI treatment. |
| Controls | – | Drug: Standard CDI treatmentPatients who have received only standard CDI treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being treated for C. difficile infection
Key inclusion criteria (6 listed)
- Age 18 years and older
- Diagnosis of C. difficile infection by clinical signs and symptoms and/or C. difficile diagnostic assay
- Received bezlotoxumab in addition to standard CDI treatment
- Age 18 years and older
- Diagnosis of C. difficile infection by clinical signs and symptoms and/or C. difficile diagnostic assay
Key exclusion criteria (2 listed)
- Diarrhea due to causes other than C. difficile
- Incomplete documentation in the electronic medical record
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 |
|---|---|---|
| BezlotoxumabBezlotoxumab 10 mg/kg IV infusion in addition to standard CDI treatment | Biological | Cases |
| Standard CDI treatmentStandard CDI treatment includes one or a combination of oral vancomycin, oral vancomycin taper and/or pulse, fidaxomicin, and fidaxomicin taper and/or pulse | Drug | Controls |
Primary outcome
Rate of CDI Recurrence
Time frame: within 12 weeks of receipt of bezlotoxumab
New episode of C. difficile infection that occurs after initial clinical cure of the baseline episode within 12 weeks of receipt of bezlotoxumab or completion of standard CDI treatment.
1 secondary outcome
Clinical cure
Time frame: 2 consecutive days after completion of standard-of-care CDI therapy.
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 28 Feb 2023.
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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.
Eric R Wenzler, PharmD principal investigator
University of Illinois Chicago
1 site 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 and Clostridium Difficile Infection Recurrence, run by University of Illinois Chicago 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 6 inclusion and 2 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 28 Feb 2023. 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.
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?
Rate of CDI Recurrence (time frame: within 12 weeks of receipt of bezlotoxumab). 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 28 Feb 2023.