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Bezlotoxumab for Clostridium Difficile
Phase 4
Waitlist Available
Led By Paul Riska, MD
Research Sponsored by Montefiore Medical Center
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 8 weeks
Awards & highlights
Study Summary
This trial will test if an antibody can prevent Clostridioides difficile (C. diff) relapse after the infection has resolved, during a subsequent period of antibiotic therapy.
Eligible Conditions
- Clostridium Difficile
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Rate of Deaths
Recurrence of C.Difficile Infection
Relapse of C. Difficile by 8 Weeks
Side effects data
From 2022 Phase 3 trial • 148 Patients • NCT0318290721%
Febrile neutropenia
14%
Headache
14%
Pyrexia
13%
Vomiting
12%
Abdominal pain
8%
Alanine aminotransferase increased
7%
Hypokalaemia
7%
Thrombocytopenia
7%
Constipation
7%
Diarrhoea
7%
Stomatitis
7%
Aspartate aminotransferase increased
7%
Anaemia
7%
Neutropenia
7%
Nausea
5%
Oral herpes
4%
Staphylococcal bacteraemia
4%
C-reactive protein increased
4%
Leukopenia
3%
Cough
3%
Urinary tract infection
3%
Sepsis
3%
Septic shock
2%
Arthralgia
2%
Rhinitis
2%
Candida sepsis
2%
Bacteraemia
2%
Klebsiella bacteraemia
2%
Pneumonia
2%
COVID-19
1%
Upper respiratory tract infection
1%
Coronavirus infection
1%
Agranulocytosis
1%
Bone marrow failure
1%
Leukocytosis
1%
Drug hypersensitivity
1%
Cytomegalovirus infection
1%
Enterobacter bacteraemia
1%
Escherichia bacteraemia
1%
Fungal sepsis
1%
Gastroenteritis
1%
Neutropenic sepsis
1%
Nosocomial infection
1%
Pharyngotonsillitis
1%
Pneumonia aspiration
1%
Pseudomonal bacteraemia
1%
Pseudomonal sepsis
1%
Soft tissue infection
1%
Streptococcal bacteraemia
1%
SARS-CoV-2 test positive
1%
Hyponatraemia
1%
Myopathy
1%
Acute myeloid leukaemia
1%
Leukaemia
1%
Nystagmus
1%
Seizure
1%
Acute respiratory distress syndrome
1%
Respiratory tract oedema
1%
Venoocclusive disease
1%
Decreased appetite
1%
Dyspnoea
1%
Vancomycin infusion reaction
1%
Loss of consciousness
1%
Neurotoxicity
1%
Intussusception
1%
Graft versus host disease
1%
Acinetobacter sepsis
1%
Adenovirus infection
1%
Clostridium difficile colitis
1%
Neutropenic infection
1%
Serratia bacteraemia
1%
Anal inflammation
1%
Mucosal inflammation
1%
Biliary-bronchial fistula
1%
Urosepsis
1%
Urticaria
1%
Bacterial sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Bezlotoxumab
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Bezlotoxumab ArmExperimental Treatment1 Intervention
Single dose of Bezlotoxumab 10mg/kg iv over 60 minutes on Day 0
Group II: No BezlotoxumabActive Control1 Intervention
Control group who are eligible as per the inclusion/exclusion criteria to the Bezlotoxumab arm, but not given Bezlotoxumab (Day 0) .
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bezlotoxumab
2018
Completed Phase 3
~380
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
442 Previous Clinical Trials
582,525 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,670 Total Patients Enrolled
4 Trials studying Clostridium Difficile
944 Patients Enrolled for Clostridium Difficile
Paul Riska, MDPrincipal Investigator - Montefiore Medical Center
Montefiore Medical Center
Duke University School Of Medicine (Medical School)
A Einstein College M-Yeshiva U (Residency)
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