Substance / Medication

Bezlotoxumab

Overview

Active Ingredient

bezlotoxumab

RxNorm CUI

1855048

Indications

Clostridioides difficile ZINPLAVA™ is indicated to reduce recurrence ofinfection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence.

Labeler: Merck Sharp & Dohme LLCUpdated: 2024-11-12T00:00:00.000ZFull label on DailyMed

Contraindications

When this intervention should not be used

None.

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Clostridial infection

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Clinical Trials

1 trials linked to this intervention

Total Trials

Recruiting

With Results

Recent Trials

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

NCT03880539Phase 4Completed4 enrolled

View all 1 trials on ClinicalTrials.gov

Research Evidence

Published studies and systematic reviews

Sort:

Efficacy, Safety, and Cost-effectiveness of Bezlotoxumab in Preventing Recurrent Clostridioides difficile Infection : Systematic Review and Meta-analysis.

Mohamed Mouhand F H, Ward Christopher, Beran Azizullah et al. · J Clin Gastroenterol · 2024

PMID: 37395627Meta-Analysis

A randomized controlled trial of precision bezlotoxumab treatment for Clostridioides difficile infection.

Psarrakis Christos, Tziolos Nikolaos-Renatos, Matzarakis Vicky et al. · Cell Rep Med · 2026

PMID: 41483804RCT

Outcomes After Fecal Microbiota Transplantation in Combination With Bezlotoxumab for Inflammatory Bowel Disease and Recurrent Clostridioides difficile Infection.

Allegretti Jessica R, Axelrad Jordan, Dalal Rahul S et al. · Am J Gastroenterol · 2024

PMID: 38501667RCT

Double-Blind, Placebo-Controlled Study of Bezlotoxumab in Children Receiving Antibacterial Treatment for Clostridioides difficile Infection (MODIFY III).

Sferra Thomas J, Merta Tomas, Neely Michael et al. · J Pediatric Infect Dis Soc · 2023

PMID: 37389891RCTFull text (PMC)

Efficacy of Bezlotoxumab in Trial Participants Infected With Clostridioides difficile Strain BI Associated With Poor Outcomes.

Johnson Stuart, Citron Diane M, Gerding Dale N et al. · Clin Infect Dis · 2021

PMID: 32735653RCT

Predicted Bezlotoxumab Exposure in Patients Who Have Received a Hematopoietic Stem Cell Transplant.

de Almeida Camila, Wong Michael, Kleijn Huub Jan et al. · Clin Ther · 2023

PMID: 36906440Trial

Genetic Association Reveals Protection against Recurrence ofInfection with Bezlotoxumab Treatment.

Shen Judong, Mehrotra Devan V, Dorr Mary Beth et al. · mSphere · 2020

PMID: 32376702TrialFull text (PMC)

Bezlotoxumab for the Prevention of Recurrent Clostridioides difficile Infection: 12-Month Observational Data From the Randomized Phase III Trial, MODIFY II.

Goldstein Ellie J C, Citron Diane M, Gerding Dale N et al. · Clin Infect Dis · 2020

PMID: 31883370Trial

A time-to-event analysis of the exposure-response relationship for bezlotoxumab concentrations and CDI recurrence.

Yee Ka Lai, Kleijn Huub Jan, Zajic Stefan et al. · J Pharmacokinet Pharmacodyn · 2020

PMID: 32048107Trial

Efficacy of bezlotoxumab based on timing of administration relative to start of antibacterial therapy for Clostridium difficile infection.

Birch Thomas, Golan Yoav, Rizzardini Giuliano et al. · J Antimicrob Chemother · 2018

PMID: 29788418Trial

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type: Substance / Medication
Fully Specified Name: Bezlotoxumab (substance)
SNOMED CT: 723524001
UMLS CUI: C4291320
RxNorm CUI: 1855048
Labeler: Merck Sharp & Dohme LLC

Clinical Data

This intervention maps to 1 entities in the Ltrl knowledge graph.

Conditions

Biomarkers

Specialists

Symptoms

Clinical Trials

Data is sourced from SNOMED CT, UMLS, and the Ltrl clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.