6 completed, 2 recruiting, 1 terminated. 9 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 9 | Completed 6, Recruiting 2, Terminated 1 |
Follow Fidaxomicin: new trials by email Literature Review of Fidaxomicin trials Research Report on Fidaxomicin
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 |
|---|---|---|---|---|---|---|
| Vancomycin Taper to Prevent Recurrent Clostridioides Difficile Fidaxomicin, Vancomycin capsule - Clostridia Difficile Colitis | Phase 3 | Recruiting | McGill University Health Centre/Research Institute of the McGill University Health Centre | 500 | 2026-04-24 | 2026-09-23 |
| Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence oral capsulized Fecal Microbiota Transplantation, Vancomycin or Fidaxomicin - Clostridioides Difficile Infection | Phase 3 | Recruiting | Benoit Guery | 100 | 2023-03-15 | 2026-07-10 |
| Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin MBK-01, Fidaxomicin - Recurrent Clostridium Difficile Infection, Primary Clostridium Difficile Infection | Phase 3 | Completed | Mikrobiomik Healthcare Company S.L. | 93 | 2021-10-29 | 2025-03-25 |
| Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection Fecal microbiota transplantation, Fidaxomicin, Vancomycin - Clostridium Difficile Infection | Phase 3 | Completed | University of Aarhus | 64 | 2016-04-01 | 2019-10-15 |
| Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection Fidaxomicin - Clostridium Difficile Infection | Phase 3 | Terminated | McMaster University | 31 | 2015-07-01 | 2023-03-24 |
| A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD) Fidaxomicin oral suspension, Fidaxomicin tablets, Vancomycin oral liquid - Clostridium Difficile-associated Diarrhea (CDAD) | Phase 3 | Completed | Astellas Pharma Europe B.V. | 148 | 2015-01-09 | 2024-11-26 |
| A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD) OPT-80, vancomycin - Clostridium Difficile | Phase 3 | Completed | Astellas Pharma Inc | 210 | 2014-06-23 | 2024-10-31 |
| Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001) fidaxomicin, Placebo - Clostridium Difficile-Associated Diarrhea (CDAD) | Phase 3 | Completed | Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 611 | 2012-10-10 | 2018-09-18 |
| Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018) Fidaxomicin, Vancomycin, Matching Placebo to Fidaxomicin - Clostridium Infections, Diarrhea | Phase 3 | Completed | Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 629 | 2006-05-02 | 2017-04-21 |
Clostridium Infections (6) · Infections (2) · Diarrhea (1) · Enterocolitis, Pseudomembranous (1) · Recurrence (1)
Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (2) · Astellas Pharma Europe B.V. (1) · Astellas Pharma Inc (1) · Benoit Guery (1) · McGill University Health Centre/Research Institute of the McGill University Health Centre (1) · McMaster University (1) · Mikrobiomik Healthcare Company S.L. (1) · University of Aarhus (1)
Canada (3) · Spain (2) · Belgium (1) · Denmark (1) · France (1) · Germany (1) · Hungary (1) · Italy (1) · Japan (1) · Poland (1) · Romania (1) · Switzerland (1) · United States (1)
Benoit Guery (1) · Christine H Lee, MD (1) · Emily McDonald, MD MSc (1) · Javier Cobo, MD (1) · Jens F Dahlerup, MD DrMSc (1) · Todd Lee, MSc MPH (1)
PMID 21288078, PMID 22752857, PMID 22752860, PMID 22752862, PMID 22752865, PMID 23715579, PMID 24599770, PMID 27182626, PMID 29893798, PMID 29934056, PMID 30610862, PMID 31773143, PMID 35463939, PMID 36906440, PMID 42665346