16 completed, 5 terminated, 3 withdrawn, 2 not yet recruiting. 11 Phase 4, 9 Phase 3, 3 Phase 2, 2 Not applicable, 2 Phase 1.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 |
|---|---|---|---|---|---|---|
| Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease Vancomycin (POC), Fidaxomicin - Inflammatory Bowel Disease (IBD), Clostridioides Difficile Infection | Phase 4 | Not yet recruiting | Brigham and Women's Hospital | 60 | 2026-09-01 | 2025-11-03 |
| 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 |
| STOP-CDI: Efficacy of Fecal Microbiota Transplantation vs Fidaxomicin vs Vancomycin in Treating and Preventing Relapse of Clostridioides Difficile Infection FMT (fecal microbiota transplantation), Fidaxomicin, Vancomycin (VAN) treatment - Clostridioides Difficile Infection, Clostridioides Difficile Infection Recurrence | Not applicable | Not yet recruiting | Medical University of Warsaw | 424 | 2025-10-01 | 2025-08-13 |
| 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 |
| Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI) Fidaxomicin - Clostridium Difficile Infection (CDI) | Withdrawn | University of Pittsburgh | 2019-08-01 | 2024-05-17 | ||
| Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection Fidaxomicin 200 mg, fecal microbiota transplantation (FMT) - Clostridium Difficile | Phase 2 | Terminated | University of Alberta | 4 | 2019-01-21 | 2022-12-13 |
| Fidaxomicin Versus Standard of Care Therapy in Solid Organ Transplant Recipients With Clostridium Difficile Infection fidaxomicin - Clostridium Difficile Infection, Solid Organ Transplant | Phase 4 | Withdrawn | University of Colorado, Denver | 2018-06-01 | 2018-08-29 | |
| A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections Fidaxomicin, Vancomycin - Clostridium Difficile Infection (CDI) | Phase 4 | Completed | University of Michigan | 144 | 2017-05-01 | 2022-03-25 |
| A Novel Faecal Microbiota Transplantation System for Treatment of Primary and Recurrent Clostridium Difficile Infection faecal human microbiota transplant (FMT), Vancomycin or Fidaxomicin - Clostridium Difficile Infection | Not applicable | Unknown | Sejtterapia Kozpont Kft. | 150 | 2017-01-01 | 2017-03-30 |
| 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 |
| Optimal Treatment for Recurrent Clostridium Difficile Fidaxomicin, Vancomycin with Taper/Pulse, Vancomycin - Clostridium, Difficile | Phase 4 | Terminated | VA Office of Research and Development | 308 | 2016-02-19 | 2026-08-21 |
| Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI) fidaxomicin - Inflammatory Bowel Disease (IBD), Clostridium Difficile Infection (CDI) | Phase 4 | Completed | Astellas Pharma Europe Ltd. | 25 | 2015-08-13 | 2024-10-31 |
| 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 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 Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population Fidaxomicin, Vancomycin - Clostridium Difficile | Phase 4 | Completed | Astellas Pharma Europe Ltd. | 364 | 2014-11-06 | 2024-10-31 |
| Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients Fidaxomicin, Treatment for CDI other than fidaxomicin Type - Clostridium Difficile Infection | Completed | Astellas Pharma S.A.S. | 296 | 2014-09-03 | 2017-10-12 | |
| 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 |
| Impact of Oral Antibiotic Treatment on C. Difficile Fidaxomicin, Metronidazole, Vancomycin - C. Difficile, Diarrhea | Phase 4 | Completed | Duke University | 33 | 2014-06-10 | 2019-10-02 |
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Clostridium Infections (17) · Diarrhea (3) · Infections (3) · Inflammatory Bowel Diseases (2) · Recurrence (2) · Colitis (1) · Colitis, Ulcerative (1) · Enterocolitis (1) · Enterocolitis, Pseudomembranous (1) · Reinfection (1) · Spinal Cord Injuries (1)
Astellas Pharma Europe Ltd. (3) · Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (3) · Astellas Pharma Europe B.V. (2) · Astellas Pharma Global Development, Inc. (1) · Astellas Pharma Inc (1) · Astellas Pharma S.A.S. (1) · Baylor College of Medicine (1) · Benoit Guery (1) · Brigham and Women's Hospital (1) · Duke University (1) · Hartford Hospital (1) · McGill University Health Centre/Research Institute of the McGill University Health Centre (1) · McMaster University (1) · Medical University of Warsaw (1) · Mikrobiomik Healthcare Company S.L. (1)
United States (11) · France (5) · Canada (4) · Germany (4) · Poland (4) · Spain (4) · Austria (3) · Denmark (3) · Greece (3) · Hungary (3) · Italy (3) · United Kingdom (3) · Belgium (2) · Czechia (2) · Romania (2)
A. Krishna Rao, MD, MS (1) · Benoit Guery (1) · Christine H Lee, MD (1) · Cornelius Clancy, MD (1) · Dale N Gerding, MD (1) · Daniel J Sexton, MD (1) · Dina Kao, MD (1) · Emily McDonald, MD MSc (1) · Eva Rakoczi, M.D. (1) · Gergely G Nagy, M.D., Ph.D. (1) · Gyorgy Paragh, M.D., D.Sc. (1)
PMID 21288078, PMID 22726461, PMID 22752857, PMID 22752860, PMID 22752862, PMID 22752865, PMID 23715579, PMID 24599770, PMID 25096079, PMID 26592763, PMID 27182626, PMID 28575523, PMID 29273269, PMID 29336929, PMID 29512244, PMID 29800295, PMID 29893798, PMID 29934056, PMID 30260412, PMID 30610862, PMID 30911926, PMID 31773143, PMID 34017999, PMID 34162264, PMID 35463939, PMID 36906440, PMID 37096495, PMID 37797310, PMID 42665346
2014 (1), U54CK000162 (1)