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Monoclonal Antibodies

Bezlotoxumab for Preventing C. difficile Infection in IBD

Phase 4

Recruiting

Research Sponsored by David Binion, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

diagnosis of IBD

active CDI receiving therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months, 24 months

Awards & highlights

Study Summary

This trial will compare Bezlotoxumab to a placebo in patients with active C. diff infection and Inflammatory Bowel Disease.

Who is the study for?

Adults over 18 with Inflammatory Bowel Disease (IBD) who are currently battling a C. diff infection and have had it before can join this trial. It's not for those without IBD, under 18, pregnant or nursing women, people who've had their colon removed, have low platelet counts, past heart issues or congestive heart failure.Check my eligibility

What is being tested?

The trial is testing Bezlotoxumab's ability to prevent the return of C. diff infections in patients with IBD like Ulcerative Colitis or Crohn's Disease. Participants will receive Bezlotoxumab to see if it helps keep the infection from coming back.See study design

What are the potential side effects?

Bezlotoxumab may cause headaches, nausea, fever, and diarrhea. Some might experience infusion-related reactions like rash or itching at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with inflammatory bowel disease (IBD).

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I am currently being treated for an active Clostridium difficile infection.

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I have had Clostridium difficile infection (CDI) before.

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I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months, 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with recurrent C. Diff infection at 12 months

Number of participants with recurrent C. Diff infection at 24 months

Number of participants with recurrent C. Diff infection at 90 days

Secondary outcome measures

Change from 12 months in disease activity scores after Bezlotoxumab at 24 months

Disease

Change from 12 months in healthcare associated charges after Bezlotoxumab at 24 months

+10 more

Side effects data

From 2022 Phase 3 trial • 148 Patients • NCT03182907

21%

Febrile neutropenia

14%

Headache

14%

Pyrexia

13%

Vomiting

12%

Abdominal pain

Alanine aminotransferase increased

Hypokalaemia

Thrombocytopenia

Constipation

Diarrhoea

Stomatitis

Aspartate aminotransferase increased

Anaemia

Neutropenia

Nausea

Oral herpes

Staphylococcal bacteraemia

C-reactive protein increased

Leukopenia

Cough

Urinary tract infection

Sepsis

Septic shock

Rhinitis

Arthralgia

Candida sepsis

Bacteraemia

Klebsiella bacteraemia

Pneumonia

COVID-19

Upper respiratory tract infection

Coronavirus infection

Agranulocytosis

Bone marrow failure

Leukocytosis

Drug hypersensitivity

Cytomegalovirus infection

Enterobacter bacteraemia

Escherichia bacteraemia

Fungal sepsis

Gastroenteritis

Neutropenic sepsis

Nosocomial infection

Pharyngotonsillitis

Pneumonia aspiration

Pseudomonal bacteraemia

Pseudomonal sepsis

Soft tissue infection

Streptococcal bacteraemia

SARS-CoV-2 test positive

Hyponatraemia

Myopathy

Acute myeloid leukaemia

Leukaemia

Nystagmus

Seizure

Acute respiratory distress syndrome

Respiratory tract oedema

Venoocclusive disease

Decreased appetite

Dyspnoea

Vancomycin infusion reaction

Loss of consciousness

Neurotoxicity

Intussusception

Graft versus host disease

Acinetobacter sepsis

Adenovirus infection

Clostridium difficile colitis

Neutropenic infection

Serratia bacteraemia

Anal inflammation

Mucosal inflammation

Biliary-bronchial fistula

Urosepsis

Urticaria

Bacterial sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Bezlotoxumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open labelExperimental Treatment1 Intervention

Single arm

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bezlotoxumab

2018

Completed Phase 3

~380

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

David Binion, MDLead Sponsor

Merck Sharp & Dohme LLCIndustry Sponsor

3,898 Previous Clinical Trials

5,062,568 Total Patients Enrolled

Media Library

Bezlotoxumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04626947 — Phase 4

Inflammatory Bowel Disease Research Study Groups: Open label

Inflammatory Bowel Disease Clinical Trial 2023: Bezlotoxumab Highlights & Side Effects. Trial Name: NCT04626947 — Phase 4

Bezlotoxumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04626947 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What purpose does this research endeavor seek to achieve?

"This trial, to be monitored for a period of 90 days, aims to measure the incidence of C. Diff recurrence after 24 months among participants. Additional objectives include evaluating changes in inflammatory markers, quality of life as measured by SIBDQ scores (10-70), and healthcare charges post Bezlotoxumab administration at 12 months."

Answered by AI

Have any other medical trials explored the efficacy of this therapeutic approach?

"At the present moment, 4 trials for this medication are taking place with none of them in Stage 3. Seven different sites across the country have contributed to these experiments, particularly in Boston, Massachusetts."

Answered by AI

What precautionary steps have been taken to ensure the safety of individuals undergoing this treatment?

"This phase 4 treatment has been given the maximum safety rating of 3 due to its approval status."

Answered by AI

Has a clinical trial of this nature ever been conducted before?

"Research into this pharmacological treatment commenced in 2019. A study sponsored by Merck Sharp & Dohme LLC was the first to probe its efficacy and safety, taking place over a 100-patient sample size. The drug's successful completion of Phase 4 trials earned it approval for general use, which has led to four ongoing studies at medical centres across two nations."

Answered by AI

To what extent is participation in this research endeavor widespread?

"Affirmative. Viewing clinicaltrials.gov reveals that this medical experiment, which was published on October 30th 2021, is currently looking for participants. It needs 50 patients from a single site to join their research team."

Answered by AI

Does this trial have any open opportunities for volunteers?

"Indeed, the data hosted on clinicaltrials.gov demonstrates that this medical investigation is currently actively recruiting participants. This trial was first made public on October 30th 2021 and has been recently updated on September 13th 2022. Approximately 50 patients must be recruited from a single site for the study to proceed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).

David Binion, MD 2021. "Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04626947.

All > Clostridium Difficile > Ibd