Evidence map›Paper›PMID 32099847›Full record

ArticleOpen forum infectious diseases2020

Exploratory Evaluation of Bezlotoxumab on Outcomes Associated With

Oliver A Cornely, Kathleen M Mullane, Thomas Birch, Sabine Hazan-Steinberg, Richard Nathan, Emilio Bouza, David P Calfee, Misoo Chung Ellison, Michael T Wong, Mary Beth Dorr

2 registry-linked trialsOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Open forum infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.2field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01241552 phase3completednot on this map

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of the Efficacy, Safety, and Tolerability of a Single Infusion of MK-3415 (Human Monoclonal Antibody to Clostridium Difficile Toxin A), MK-6072 (Human Monoclonal Antibody to Clostridium Difficile Toxin B), and MK-3415A (Human Monoclonal Antibodies to Clostridium Difficile Toxin A and Toxin B) in Patients Receiving Antibiotic Therapy for Clostridium Difficile Infection (MODIFY I)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2011 to 2014Enrolled1,452ConditionsClostridium Difficile InfectionArmsMK-3415, MK-6072, MK-3415A, Placebo, SOC
NCT01513239 phase3completednot on this map

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of a Single Infusion of MK-6072 (Human Monoclonal Antibody to Clostridium Difficile Toxin B), and MK-3415A (Human Monoclonal Antibodies to Clostridium Difficile Toxin A and B) in Patients Receiving Antibiotic Therapy for Clostridium Difficile Infection (MODIFY II)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2012 to 2015Enrolled1,203ConditionsClostridium Difficile InfectionArmsMK-6072, MK-3415A, Placebo, SOC
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 11 citations in OpenAlex.

  1. Management ofEClinicalMedicine · 2025
    Review
  2. The Role of Bezlotoxumab for the Prevention of RecurrentAntibiotics (Basel, Switzerland) · 2022
    Review
  3. Review
  4. Review
  5. Investigational Treatment Agents for RecurrentJournal of experimental pharmacology · 2020
    Review
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 3 countries.

Oliver A CornelyCologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Department I of Internal Medicine, Clinical Trials Centre Cologne (ZKS Köln), University of Cologne, Cologne, Germany.
Kathleen M MullaneSection of Infectious Diseases, Department of Medicine, University of Chicago, Chicago, Illinois, USA.
Thomas BirchHoly Name Medical Center, Teaneck, New Jersey, USA.
Sabine Hazan-SteinbergVentura Clinical Trials, Ventura, California, USA.
Richard NathanIdaho Falls Infectious Diseases, Idaho Falls, Idaho, USA.
Emilio BouzaDepartment of Medicine, Universidad Complutense, Department of Microbiology and Infectious Diseases, Hospital Gregorio Maranon, CIBERES, Madrid, Spain.
David P CalfeeWeill Cornell Medicine, New York, New York, USA.
Misoo Chung EllisonMerck & Co., Inc., Kenilworth, New Jersey, USA.
Michael T WongMerck & Co., Inc., Kenilworth, New Jersey, USA.
Mary Beth DorrMerck & Co., Inc., Kenilworth, New Jersey, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USCentro de Investigación Biomédica en Red · ESCornell University · USHoly Name Medical Center · USUniversity of Chicago · USUniversity of Cologne · DEVentura College · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe incidence of

methodsParticipants received a single infusion of bezlotoxumab (10 mg/kg) or placebo during anti-CDI antibacterial treatment. A post hoc analysis of CDI-related outcomes was conducted in subgroups of MODIFY I/II participants with and without cancer.

resultsOf 1554 participants in the modified intent-to-treat (mITT) population, 382 (24.6%) were diagnosed with cancer (bezlotoxumab 190, placebo 192). Of participants without cancer, 591 and 581 received bezlotoxumab and placebo, respectively. In the placebo group, initial clinical cure (ICC) was achieved by fewer cancer participants vs participants without cancer (71.9% vs 83.1%; absolute difference, -11.3%; 95% CI, -18.6% to -4.5%); however, CDI recurrence (rCDI) rates were similar in cancer (30.4%) and noncancer (34.0%) participants. In participants with cancer, bezlotoxumab treatment had no effect on ICC rate compared with placebo (76.8% vs 71.9%), but resulted in a statistically significant reduction in rCDI vs placebo (17.8% vs 30.4%; absolute difference, -12.6%; 95% CI, -22.5% to -2.7%).

conclusionsIn this post hoc analysis of participants with cancer enrolled in MODIFY I/II, the rate of rCDI in bezlotoxumab-treated participants was lower than in placebo-treated participants. Additional studies are needed to confirm these results. CLINICAL

trial registrationMODIFY I (NCT01241552), MODIFY II (NCT01513239).

Indexed as

cancerCDI recurrenceClostridioides difficilehematologic malignancysolid tumor

Identifiers

PMID32099847
PMCPMC7029680
OpenAlexW3004184130

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.