Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection (BEZLO)
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ClinicalTrials.gov Identifier: NCT03880539 |
Recruitment Status :
Completed
First Posted : March 19, 2019
Last Update Posted : May 26, 2022
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Condition or disease | Intervention/treatment | Phase |
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Clostridium Difficile Infection Recurrence | Drug: bezlotoxumab Drug: Vancomycin Oral | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | The intervention group will consist of a single arm of patients treated with BEZLO + SOC oral VAN pulse/taper for multi-recurrent CDI, with a planned enrollment of 12 patients. To achieve the aim of the proposed study, we will compare the efficacy of BEZLO + SOC oral VAN pulse/taper to a historical cohort of patients treated with SOC oral VAN pulse/taper only. These patients will be matched 1:6 on criteria previously outlined in this proposal (BEZLO + SOC, n=12; SOC comparator, n=72; total number of patients in study, n=84). |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Historically-controlled Clinical Trial of the Efficacy and Safety of Bezlotoxumab (BEZLO) in Addition to Standard of Care (SOC) Vancomycin for the Treatment of Multi-recurrent Clostridium Difficile Infection (CDI) |
Actual Study Start Date : | June 25, 2019 |
Actual Primary Completion Date : | November 18, 2021 |
Actual Study Completion Date : | November 18, 2021 |

Arm | Intervention/treatment |
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BEZLO + SOC taper
Single arm of patients treated with BEZLO + SOC oral VAN pulse/taper.
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Drug: bezlotoxumab
Adding BEZLO to SOC oral VAN pulse/taper
Other Name: Zinplava Drug: Vancomycin Oral SOC vancomycin pulse/taper
Other Name: Firvanq |
- Rate of CDI reoccurrence at 12 weeks [ Time Frame: 12 weeks ]If diarrhea resolves (defined as <2 loose stools per day for at least 2 consecutive days) and subsequently begins again (3 or more loose stools in 24 hours or less for at least 2 consecutive days), this will represent a new episode of diarrhea. If there is a new episode of diarrhea at any time during the 12-week study period, an unscheduled visit will be conducted. A stool sample will be provided for any new episode of diarrhea which occurs and a stool test for toxigenic C. difficile (NAAT plus EIA) will be performed. CDI reoccurrence will be defined as new episode of diarrhea and positive stool test for toxigenic C. difficile (NAAT plus EIA).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (Interventional):
- i) age 18 years or older;
- ii) diagnosis of multi-recurrent CDI, defined as passage of 3 or more loose stools in 24 hours or less for at least 2 consecutive days and a positive stool test for toxigenic C. difficile (nucleic acid amplification test [NAAT] and toxin enzyme immunoassay [EIA] positive), with 2 or more confirmed prior CDI episodes;
- iii) receiving or planning to receive a 10- to 14-day course of SOC therapy with oral VAN followed by a tapered VAN regimen for at least 4 weeks;
- iv) patient highly unlikely to become pregnant due to being female and not of reproductive potential or female of reproductive potential agreeing to be abstinent or using 2 acceptable methods of birth control starting at enrollment and through the 16-week study period; and
- v) patient or legal representative voluntarily agreeing to participate by providing written informed consent after the nature of the study has been fully explained.
Inclusion Criteria (Historical Control):
- i) age 18 years or older
- ii) diagnosis of multi-recurrent CDI
- iii) received 10- to 14-day course of SOC therapy with oral VAN followed by a tapered VAN regimen.
Exclusion Criteria:
- i) active chronic diarrheal illness, such as (but not limited to) ulcerative colitis or Crohn's disease or with a condition such that they routinely pass loose stool
- ii) planned surgery for CDI within 24 hours
- iii) positive pregnancy test in the 48 hours before the infusion or unwilling to undergo pregnancy testing if a pre-menopausal female who is not sterilized and therefore has the potential to bear a child
- iv) breastfeeding or planning to breastfeed prior to the completion of the study period
- v) previous receipt of BEZLO
- vi) receipt of immune globulin within 6 months prior to enrollment or planning to receive immune globulin prior to completion of the 16-week study period
- vii) receipt of non-SOC CDI therapy within 14 days prior to enrollment
- viii) planned treatment with SOC therapy for longer than 6 weeks
- ix) receipt of medications to control diarrhea such as loperamide, diphenoxylate hydrochloride/atropine sulfate at any time prior to completion of the 16-week study period
- x) medical history of decompensated congestive heart failure

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880539
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 |
Principal Investigator: | Lisa A Clough, MD | University of Kansas Medical Center |
Responsible Party: | Lisa Clough, Principal Investigator, University of Kansas Medical Center |
ClinicalTrials.gov Identifier: | NCT03880539 |
Other Study ID Numbers: |
Study00143405 |
First Posted: | March 19, 2019 Key Record Dates |
Last Update Posted: | May 26, 2022 |
Last Verified: | May 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
C.diff Clostridium Difficile recurrence Bezlotoxumab CDI |
Infections Communicable Diseases Clostridium Infections Recurrence Disease Attributes Pathologic Processes |
Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Vancomycin Anti-Bacterial Agents Anti-Infective Agents |