19 completed. 19 Phase 2, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 19 | Completed 19 |
| Phase 1 | 2 | Completed 2 |
Follow Clostridium Difficile Infection: new trials by email Literature Review of Clostridium Difficile Infection trials Research Report on Clostridium Difficile Infection
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 |
|---|---|---|---|---|---|---|
| ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection Ibezapolstat, Vancomycin - Clostridium Difficile Infection | Phase 2 | Completed | Acurx Pharmaceuticals Inc. | 53 | 2020-03-06 | 2025-01-17 |
| 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 |
| The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation Low Dose FMT Capsule DE, Single Dose FMT Capsule DE, Placebo oral capsule - Clostridium Difficile Infection, C.Difficile Diarrhea | Phase 2 | Completed | University of Wisconsin, Madison | 1 | 2019-03-21 | 2021-03-15 |
| Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection VE303, Placebo - Clostridium Difficile Infection Recurrence, Clostridium Difficile Infection | Phase 2 | Completed | Vedanta Biosciences, Inc. | 79 | 2019-02-08 | 2023-07-03 |
| Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD MGB-BP-3 - Clostridium Difficile Infection | Phase 2 | Completed | MGB Biopharma Limited | 34 | 2019-02-07 | 2020-04-15 |
| Vancomycin for C Difficile NAAT+/EIA- Hematology Oncology Patients Vancomycin Oral Capsule, Placebo Oral Capsule - Clostridium Difficile Infection, Hematologic Diseases | Phase 2 | Completed | Medical College of Wisconsin | 9 | 2018-06-01 | 2026-04-15 |
| Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection Vancomycin, Placebo - Recurrent Clostridium Difficile Infection, Clostridium Difficile Infection | Phase 2 | Completed | University of Wisconsin, Madison | 79 | 2018-05-21 | 2025-05-25 |
| Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection CP101 - Clostridium Difficile Infection, Recurrent Clostridium Difficile Infection | Phase 2 | Completed | Finch Research and Development LLC. | 132 | 2018-05-01 | 2022-08-30 |
| The ICON Study: Outcomes After FMT for Patients With IBD and CDI Fecal Microbiota Transplantation - Inflammatory Bowel Diseases, Clostridium Difficile Infection | Phase 1 / Phase 2 | Completed | Brigham and Women's Hospital | 50 | 2017-08-01 | 2021-02-10 |
| Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection RBX2660, Standard of Care Antibiotics - Clostridium Difficile Infection | Phase 2 | Completed | Rebiotix Inc. | 272 | 2015-10-01 | 2021-03-26 |
| A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI) Ridinilazole, Fidaxomicin - Clostridium Difficile Infection | Phase 2 | Completed | Summit Therapeutics | 27 | 2014-12-01 | 2017-10-12 |
| A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD) SMT19969, Vancomycin - Clostridium Difficile Infection | Phase 2 | Completed | Summit Therapeutics | 100 | 2014-04-01 | 2016-10-20 |
| Study of a Candidate Clostridium Difficile Toxoid Vaccine in Healthy Adult Subjects Aged 40 to 75 Years in Japan Clostridium difficile Toxoid Vaccine, 0.9% normal saline - Clostridium Difficile Infection | Phase 1 / Phase 2 | Completed | Sanofi Pasteur, a Sanofi Company | 102 | 2013-07-01 | 2018-07-18 |
| Multi-Centre Trial of Fresh vs. Frozen-and-Thawed FMT for Recurrent CDI Fresh FMT, Frozen-and-Thawed FMT - Clostridium Difficile Infection | Phase 2 | Completed | McMaster University | 232 | 2012-07-01 | 2021-06-07 |
| Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection VP20621, Placebo - Clostridium Difficile Infection | Phase 2 | Completed | Shire | 173 | 2011-06-27 | 2021-06-10 |
| Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD) Cadazolid, Vancomycin, Placebo-matching cadazolid - Clostridium Difficile Infection | Phase 2 | Completed | Actelion | 84 | 2011-01-25 | 2017-06-14 |
| Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults Clostridium difficile toxoids A and B (Low-dose with adjuvant), Clostridium difficile toxoids A and B (Low-dose without adjuvant), Clostridium difficile toxoids A and B (high-dose with adjuvant) - Clostridium Difficile Infection, Diarrhea | Phase 2 | Completed | Sanofi Pasteur, a Sanofi Company | 650 | 2010-10-01 | 2018-07-18 |
| Study of CB-183,315 in Participants With Clostridium Difficile Infection CB-183,315, Placebo, Vancomycin - Clostridium Difficile Infection, Diarrhea | Phase 2 | Completed | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 210 | 2010-04-01 | 2018-09-11 |
| Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection 0.9% Normal Saline, Clostridium difficile toxoid vaccine, Clostridium difficile toxoid vaccine with adjuvant - Diarrhea, Clostridium Difficile Infection | Phase 2 | Completed | Sanofi Pasteur, a Sanofi Company | 116 | 2009-02-01 | 2013-09-17 |
Clostridium Infections (19) · Diarrhea (6) · Enterocolitis, Pseudomembranous (2) · Inflammatory Bowel Diseases (2) · Bacterial Infections (1) · Colitis, Ulcerative (1) · Crohn Disease (1) · Diabetes Insipidus, Neurogenic (1) · Hematologic Diseases (1) · Recurrence (1) · Signs and Symptoms, Digestive (1)
Bacterial Infections and Mycoses (19) · Gram-Positive Bacterial Infections (19) · Infections (19) · Bacterial Infections (18) · Pathological Conditions, Signs and Symptoms (6) · Signs and Symptoms (6) · Signs and Symptoms, Digestive (5) · Digestive System Diseases (4) · Gastroenteritis (4) · Gastrointestinal Diseases (4) · Intestinal Diseases (4) · Enterocolitis (2) · Colitis (1) · Colonic Diseases (1) · Diabetes Insipidus (1)
Vancomycin (6) · Fecal Microbiota Transplantation (4) · Saline Solution (3) · Adjuvants, Pharmaceutic (2) · ridinilazole (2) · Anti-Bacterial Agents (1) · CB-183,315 (1) · Fidaxomicin (1) · Ibezapolstat (1) · MGB-BP-3 (1) · Sodium Chloride (1) · bezlotoxumab (1) · cadazolid (1)
Sanofi Pasteur, a Sanofi Company (3) · Brigham and Women's Hospital (2) · Summit Therapeutics (2) · University of Wisconsin, Madison (2) · Actelion (1) · Acurx Pharmaceuticals Inc. (1) · Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (1) · Finch Research and Development LLC. (1) · MGB Biopharma Limited (1) · McMaster University (1) · Medical College of Wisconsin (1) · Rebiotix Inc. (1) · Shire (1) · Vedanta Biosciences, Inc. (1)
United States (17) · Canada (9) · United Kingdom (3) · Germany (2) · Belgium (1) · Czechia (1) · Italy (1) · Japan (1) · Spain (1) · Sweden (1) · Switzerland (1)
Arnab Ray, MD (1) · Christine Lee, MD (1) · Darrell Pardi, MD (1) · Jessica R Allegretti, MD, MPH (1) · Michael H Silverman, MD (1) · Miroslav Ravic, MD (1) · Nasia Safdar, MD PhD (1) · Nasia Safdar, MD, PhD (1) · Pascal Charef, DVM (1) · Richard Vickers, PhD (1) · Silvia Munoz-Price, M.D., Ph.D. (1) · Zain Kassam, MD, MPH (1)
PMID 25942722, PMID 26248357, PMID 26348734, PMID 26433782, PMID 26757463, PMID 27013431, PMID 27432604, PMID 27707993, PMID 27943501, PMID 28461207, PMID 29116880, PMID 29718329, PMID 31537446, PMID 35134880, PMID 35279084, PMID 37060545, PMID 39006315, PMID 40516571, PMID 40601321, PMID 41245385, PMID 42286373
2008 (1), 2015 (1)