NCT03937999 is a Phase 4 clinical trial of Bezlotoxumab in Clostridium Difficile, sponsored by Montefiore Medical Center.

Who is sponsoring NCT03937999?

NCT03937999 is sponsored by Montefiore Medical Center.

What drugs are being tested in NCT03937999?

Interventions in NCT03937999: Bezlotoxumab.

What condition does NCT03937999 study?

NCT03937999 studies Clostridium Difficile.

Is NCT03937999 still recruiting?

NCT03937999 is currently terminated. Last updated 9 November 2022.

Are results published for NCT03937999?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-11-09 · How we verify

NCT03937999

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 4 Results posted Last updated 9 November 2022

What this trial tests

Phase 4 trial testing Bezlotoxumab in Clostridium Difficile in 1 participant. Terminated before completion.

Timeline

30 August 2019

Primary endpoint
15 May 2022

15 May 2022

Quick facts

Lead sponsor	Montefiore Medical Center
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1
Start date	30 August 2019
Primary completion	15 May 2022
Estimated completion	15 May 2022
Sites	1 location across United States

Drugs / interventions tested

Bezlotoxumab (BEZLOTOXUMAB) — full drug profile →

Conditions studied

Clostridium Difficile — all drugs for Clostridium Difficile →

Sponsor

Montefiore Medical Center

Who can join

60 and older, any sex, with Clostridium Difficile. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Recurrence of C.Difficile Infection Primary · within 4 weeks

Group	Value	95% CI
No Bezlotoxumab	0

Recurrence of C.Difficile Infection Secondary · within 8 weeks

Group	Value	95% CI
No Bezlotoxumab	0

Rate of Deaths Secondary · within 8 weeks

Group	Value	95% CI
No Bezlotoxumab	0

Relapse of C. Difficile by 8 Weeks Secondary · 8 weeks

Group	Value	95% CI
No Bezlotoxumab	1

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Exotoxin-Targeted Drug Modalities as Antibiotic Alternatives.
Sakari M, Laisi A, Pulliainen AT. · · 2022 · cited 23× · PMID 35099182 · DOI 10.1021/acsinfecdis.1c00296
Risk Factors Associated with Recurrent <i>Clostridioides difficile</i> Infection.
Negrut N, Bungau S, Behl T, Khan SA, et al · · 2020 · cited 23× · PMID 32967323 · DOI 10.3390/healthcare8030352

Verify or expand the search:

Other trials of Bezlotoxumab

Trials testing the same drug.

NCT05304715 — Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection · Phase 2 · completed
NCT04626947 — Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD). · Phase 4 · terminated
NCT04317963 — Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection · completed
NCT03829475 — ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI · Phase 2 · completed
NCT03756454 — Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Ful · Phase 4 · terminated

Other recruiting trials for Clostridium Difficile

Currently open trials in the same condition.

NCT06071312 — FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach · Phase 1, PHASE2 · recruiting
NCT05622721 — REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs · active not recruiting

Other Montefiore Medical Center trials

Trials by the same sponsor.

NCT07224061 — Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools · NA · not yet recruiting
NCT06775886 — Effect of Personalized Accelerated Pacing in Symptomatic Patients With Non-Obstructive Hypertrophic Cardiomyopathy · NA · terminated
NCT06919094 — A Virtual Life Story Club Intervention to Improve Loneliness and Apathy in Community-Dwelling Older Adults · NA · recruiting
NCT07076069 — The Effect of Multimodal Pain Regimen on Use of Narcotics After Rotator Cuff Tear Repair · Phase 4 · recruiting
NCT07037940 — Physician Response Evaluation With Contextual Insights vs. Standard Engines - Artificial Intelligence RAG vs LLM Clinica · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03937999 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Montefiore Medical Center
Last refreshed: 9 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03937999.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing