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Bezlotoxumab for Clostridium Difficile Colitis

Phase 4

Waitlist Available

Research Sponsored by Michael E Villarreal, MD

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30-days

Awards & highlights

Study Summary

This trial is studying a new medication to see if it can help decrease complications for people with a severe infection that requires surgery.

Eligible Conditions

Clostridium Difficile Colitis
Clostridium Sepsis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30-days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30-days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30-days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Mortality

Secondary outcome measures

Heart Failure

Hepatic Failure

Renal Failure

+1 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

Coronavirus infection

Upper respiratory tract 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

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BezlotoxumabExperimental Treatment1 Intervention

Patients receiving Bezlotoxumab post-operatively.

Group II: Normal SalinePlacebo Group1 Intervention

Patients receiving normal saline as a placebo post-operatively.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bezlotoxumab

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Michael E Villarreal, MDLead Sponsor

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,566 Total Patients Enrolled

Frequently Asked Questions

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

Are there any risks associated with Bezlotoxumab treatments?

"The safety of Bezlotoxumab is rated highly, given its Phase 4 status and approval for use. Therefore, our team at Power assigned it a score of 3 out of 3 on their scale."

Answered by AI

Is this clinical trial a pioneering endeavor?

"Since its inception in 2019, research for bezlotoxumab has been conducted with the help of Merck Sharp & Dohme LLC. After a successful Phase 4 trial involving 100 participants, the drug was approved and is now being tested across two nations at four distinct clinical sites."

Answered by AI

How many volunteers are currently involved in this research?

"Indeed, the information hosted on clinicaltrials.gov demonstrates that this medical study is currently recruiting participants. This research was initially posted in August of 2019 and most recently revised in October 2021 - with a target enrolment number of 100 individuals from 1 distinct site."

Answered by AI

Have there been any other investigations that have utilized Bezlotoxumab?

"Currently, 4 research studies are dedicated to Bezlotoxumab with none being in the final phase. Boston is a primary hub for these trials, though there are other 7 sites running tests as well."

Answered by AI

Is there an ongoing enrollment process for this trial?

"Affirmative. The details of this clinical trial, which was inaugurated on August 19th 2019 and amended October 26th 2021 are available online via clinicaltrials.gov. This research is recruiting 100 participants from one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery.

Michael E Villarreal, MD 2019. "Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03756454.