| Zinplava (bezlotoxumab) / Merck (MSD) |
NCT03756454: Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery. |
|
|
| Terminated | 4 | 5 | US | Bezlotoxumab, Normal Saline | Michael E Villarreal, MD, Merck Sharp & Dohme LLC | Clostridia Difficile Colitis, Clostridium; Sepsis | 05/22 | 05/22 | | |
2021-004924-14: Bezlotoxumab or fecal transplant for recurrent C. difficile infections Bezlotoxumab of poeptransplantatie voor terugkerende infecties met C. difficile |
|
|
| Not yet recruiting | 4 | 66 | Europe | Concentrate for solution for infusion, Zinplava | Leiden University Medical Center, MERCK SHARP & DOHME CORP. | recurrent C. difficile infection, recurrent infection of the gut by the C. difficile bacterium, Diseases [C] - Bacterial Infections and Mycoses [C01] | | | | |
NCT04626947: Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD). |
|
|
| Terminated | 4 | 19 | US | Bezlotoxumab | David Binion, MD, Merck Sharp & Dohme LLC | Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease, C. Diff. Infections | 04/24 | 05/24 | | |
| Withdrawn | 4 | 66 | Europe | Bezlotoxumab, Fecal Microbiota Transplantation (FMT), Vancomycin oral | Leiden University Medical Center, OLVG, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, Medical Center Haaglanden | Clostridium Infections, Clostridioides Difficile, Enterocolitis, Pseudomembranous | 07/24 | 12/24 | | |
| Active, not recruiting | 2 | 61 | US | Bezlotoxumab, Zinplava, Placebo, Saline, Fecal Microbiota Transplantation, FMT | Brigham and Women's Hospital | Inflammatory Bowel Diseases, Clostridium Difficile Infection | 08/23 | 06/25 | | |
| Completed | 2 | 44 | Europe | Bezlotoxumab, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians., Normal saline 0.9% or 5% dextrose water, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians | Hellenic Institute for the Study of Sepsis | Clostridioides Difficile Infection, Stool Microbiome, Organ Dysfunction Syndrome, Clostridioides Difficile Infection Recurrence, Mortality | 06/23 | 06/23 | | |
| Completed | N/A | 24 | US | Fecal microbiota transplantation ± bezlotoxumab, FMT; Zinplava | Alexander Khoruts | Recurrent C. Difficile Infection | 10/24 | 10/24 | | |
| Completed | N/A | 153 | Europe | Microbiome analysis | Hellenic Institute for the Study of Sepsis | Clostridioides Difficile Infection | 03/22 | 03/22 | | |
NCT04317963: Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection |
|
|
| Completed | N/A | 180 | US | Bezlotoxumab, Standard CDI treatment | University of Illinois at Chicago, Merck Sharp & Dohme LLC | Clostridium Difficile Infection, Clostridium Difficile Infection Recurrence | 02/23 | 02/23 | | |
