Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection

NCT03880539 | Completed Phase 4 FDA Drug

• 1 other identifier: Study00143405
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study to collect information from people that have Clostridium difficile infection (CDI) and are treated with a standard antibiotic treatment in which the antibiotic dose is gradually reduced over 6 weeks and bezlotoxumab (BEZLO), an approved monoclonal antibody targeting C. difficile toxin, which has shown to reduce CID recurrence when used in combination with standard antibiotic treatment.

Conditions

Clostridium Difficile Infection Recurrence

Keywords

C.diff; Clostridium Difficile; recurrence; Bezlotoxumab; CDI

Outcome Measures

Primary Outcomes (1)

• Rate of CDI reoccurrence at 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).

  12 weeks

Study Arms (1)

BEZLO + SOC taper

OTHER

Single arm of patients treated with BEZLO + SOC oral VAN pulse/taper.

Drug: bezlotoxumab; Drug: Vancomycin Oral

Interventions

bezlotoxumab DRUG

Adding BEZLO to SOC oral VAN pulse/taper

Also known as: Zinplava

BEZLO + SOC taper

Vancomycin Oral DRUG

SOC vancomycin pulse/taper

Also known as: Firvanq

BEZLO + SOC taper

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Recurrence

Interventions

bezlotoxumab; Vancomycin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Lisa A Clough, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 19, 2019
• Study Start: June 25, 2019
• Primary Completion: November 18, 2021
• Study Completion: November 18, 2021
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

US (1)