9 completed, 3 terminated, 1 unknown, 1 withdrawn. 6 Phase 4, 3 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 6 | Terminated 3, Completed 1, Unknown 1, Withdrawn 1 |
| Phase 3 | 3 | Completed 3 |
| Phase 2 | 2 | Completed 2 |
Follow bezlotoxumab: new trials by email Literature Review of bezlotoxumab trials Research Report on bezlotoxumab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection Bezlotoxumab, Normal saline 0.9% or 5% dextrose water - Clostridioides Difficile Infection, Stool Microbiome | Phase 2 | Completed | Hellenic Institute for the Study of Sepsis | 44 | 2022-04-13 | 2026-03-04 |
| Bezlotoxumab Versus FMT for Multiple Recurrent CDI Bezlotoxumab, Fecal Microbiota Transplantation (FMT), Vancomycin oral - Clostridium Infections, Clostridioides Difficile | Phase 4 | Withdrawn | Leiden University Medical Center | 2022-01-01 | 2023-03-28 | |
| Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD). Bezlotoxumab - Inflammatory Bowel Diseases, Ulcerative Colitis | Phase 4 | Terminated | David Binion, MD | 19 | 2021-10-14 | 2025-06-05 |
| Bezlotoxumab Efficacy and Tolerability in Cancer Patient Bezlotoxumab Injection - Clostridium Difficile Infection Recurrence | Phase 4 | Unknown | The Cooper Health System | 132 | 2020-07-01 | 2020-06-04 |
| Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection Bezlotoxumab, Standard CDI treatment - Clostridium Difficile Infection, Clostridium Difficile Infection Recurrence | Completed | University of Illinois at Chicago | 180 | 2020-02-12 | 2023-02-28 | |
| ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI Bezlotoxumab, Placebo, Fecal Microbiota Transplantation - Inflammatory Bowel Diseases, Clostridium Difficile Infection | Phase 2 | Completed | Brigham and Women's Hospital | 61 | 2020-01-01 | 2025-12-09 |
| Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence. Bezlotoxumab Injection [Zinplava] - Clostridium Difficile Infection | Completed | Fundacion SEIMC-GESIDA | 869 | 2019-10-01 | 2023-06-26 | |
| Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics. Bezlotoxumab - Clostridium Difficile | Phase 4 | Terminated | Montefiore Medical Center | 1 | 2019-08-30 | 2022-11-09 |
| Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery. Bezlotoxumab, Normal Saline - Clostridia Difficile Colitis, Clostridium; Sepsis | Phase 4 | Terminated | Ohio State University | 5 | 2019-08-19 | 2026-06-18 |
| Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection bezlotoxumab, Vancomycin Oral - Clostridium Difficile Infection Recurrence | Phase 4 | Completed | University of Kansas Medical Center | 4 | 2019-06-25 | 2022-05-26 |
| Rescue FMT with Bezlotoxumab for Recurrent C. Difficile Infection Fecal microbiota transplantation ± bezlotoxumab - Recurrent C. Difficile Infection | Completed | Alexander Khoruts | 24 | 2018-05-01 | 2024-11-01 | |
| Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001) Bezlotoxumab, Placebo, Antibacterial drug treatment (ABD) - Clostridium Difficile Infection | Phase 3 | Completed | Merck Sharp & Dohme LLC | 148 | 2018-03-27 | 2023-07-27 |
| A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002) MK-6072, MK-3415A, Placebo - Clostridium Difficile Infection | Phase 3 | Completed | Merck Sharp & Dohme LLC | 1203 | 2012-02-01 | 2018-09-05 |
| A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001) MK-3415, MK-6072, MK-3415A - Clostridium Difficile Infection | Phase 3 | Completed | Merck Sharp & Dohme LLC | 1452 | 2011-10-10 | 2018-09-05 |
Clostridium Infections (9) · Colitis, Ulcerative (2) · Crohn Disease (2) · Enterocolitis, Pseudomembranous (2) · Inflammatory Bowel Diseases (2) · Diarrhea (1) · Recurrence (1) · Sepsis (1)
Merck Sharp & Dohme LLC (3) · Alexander Khoruts (1) · Brigham and Women's Hospital (1) · David Binion, MD (1) · Fundacion SEIMC-GESIDA (1) · Hellenic Institute for the Study of Sepsis (1) · Leiden University Medical Center (1) · Montefiore Medical Center (1) · Ohio State University (1) · The Cooper Health System (1) · University of Illinois at Chicago (1) · University of Kansas Medical Center (1)
United States (8) · Spain (2) · Argentina (1) · Brazil (1) · Colombia (1) · Czechia (1) · Germany (1) · Greece (1) · Hungary (1) · Malaysia (1) · Mexico (1) · Netherlands (1) · Norway (1) · Poland (1) · Portugal (1)
David Binion, MD (1) · Eric R Wenzler, PharmD (1) · Evangelos J Giamarellos-Bourboulis, MD, PhD (1) · J van Prehn (1) · Lisa A Clough, MD (1) · Paul Riska, MD (1)
PMID 28121498, PMID 29538686, PMID 29788418, PMID 30060024, PMID 30227108, PMID 30455246, PMID 30460321, PMID 31411386, PMID 31628838, PMID 32099847, PMID 32376702, PMID 32504314, PMID 36661328, PMID 27316794, PMID 31846705, PMID 31883370, PMID 32101275, PMID 36906440, PMID 37389891, PMID 41427863, PMID 41483804
2017 (1), 2019 (1)