Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.

NCT03937999 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2019-10212
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine whether the human monoclonal antibody, bezlotoxumab administered AFTER acute Clostridioides difficile (C.diff) has resolved, but during a period of subsequent antibiotic therapy, will eliminate the high risk of C. diff relapse.

Conditions

Clostridium Difficile

Keywords

clostridium difficile; diarrhea

Outcome Measures

Primary Outcomes (1)

• Recurrence of C.Difficile Infection

  within 4 weeks

Secondary Outcomes (3)

• Recurrence of C.Difficile Infection

  within 8 weeks

• Rate of Deaths

  within 8 weeks

• Relapse of C. Difficile by 8 Weeks

  8 weeks

Study Arms (2)

Bezlotoxumab Arm

EXPERIMENTAL

Single dose of Bezlotoxumab 10mg/kg iv over 60 minutes on Day 0

Drug: Bezlotoxumab

No Bezlotoxumab

NO INTERVENTION

Control group who are eligible as per the inclusion/exclusion criteria to the Bezlotoxumab arm, but not given Bezlotoxumab (Day 0) .

Interventions

Bezlotoxumab DRUG

Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial.

Also known as: Zinplava

Bezlotoxumab Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• C diff diagnosed within 90 days
• Receipt of high-risk antibiotics for C diff (e.g. Beta-lactams, carbapenems) in an inpatient setting
• Age 60 years and older

You may not qualify if:

• Receipt of current C.diff active antibiotics (oral vancomycin, fidaxomycin, metronidazole, tigecycline/ doxycycline, nitazoxanide, rifamycin) within 72hrs.
• Not Expected to survive 8 weeks
• Prior or planned fecal microbiota transplant or Bezlotoxumab use
• Congestive heart failure (a potential risk of Bezlotoxumab)

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Diarrhea

Interventions

bezlotoxumab

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Paul Riska, MD
• Organization: Montefiore Medical Center

priska@montefiore.org

718-920-6494

Study Officials

• Paul Riska, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention group compared to concurrent and historical control groups

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 6, 2019
• Study Start: August 30, 2019
• Primary Completion: May 15, 2022
• Study Completion: May 15, 2022
• Last Updated: November 9, 2022
• Results First Posted: November 9, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)