Fidaxomicin
- Generic Name
- Fidaxomicin
- Brand Names
- Dificid, Dificlir
- Drug Type
- Small Molecule
- Chemical Formula
- C52H74Cl2O18
- CAS Number
- 873857-62-6
- Unique Ingredient Identifier
- Z5N076G8YQ
- Background
Fidaxomicin is a novel macrolide antibiotic used in the treatment of diarrhea caused by Clostridioides (formerly Clostridium) difficile in adult and pediatric patients over the age of 6 months. Fidaxomicin is a naturally-occurring 18-member macrocycle derived from fermentation. Because fidaxomicin contains an 18-membered lactone ring in its structure, it is ...
- Indication
用于治疗艰难梭菌（又名难辨梭状芽孢杆菌）感染相关性腹泻。
- Associated Conditions
- Clostridium Difficile Associated Diarrhea (CDAD)
- Associated Therapies
- -
A Study to Assess the Effects of Multiple Doses of Fidaxomicin on a Single Dose of Rosuvastatin in Healthy Male Subjects
- First Posted Date
- 2014-03-11
- Last Posted Date
- 2014-05-21
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Target Recruit Count
- 25
- Registration Number
- NCT02083627
- Locations
- 🇩🇪
Parexel GmbH, Berlin, Germany
Impact of Oral Antibiotic Treatment on C. Difficile
- Conditions
- Interventions
- First Posted Date
- 2014-02-06
- Last Posted Date
- 2019-10-02
- Lead Sponsor
- Duke University
- Target Recruit Count
- 33
- Registration Number
- NCT02057198
- Locations
- 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin
- Conditions
- Interventions
- First Posted Date
- 2013-03-26
- Last Posted Date
- 2017-06-28
- Lead Sponsor
- Hartford Hospital
- Target Recruit Count
- 34
- Registration Number
- NCT01818141
- Locations
- 🇺🇸
Hartford Hospital, Hartford, Connecticut, United States
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects
- Conditions
- Interventions
- First Posted Date
- 2013-03-19
- Last Posted Date
- 2014-05-21
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 36
- Registration Number
- NCT01813448
- Locations
- 🇺🇸
Parexel, Glendale, California, United States
A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System
- Conditions
- Interventions
- First Posted Date
- 2013-01-25
- Last Posted Date
- 2020-01-13
- Lead Sponsor
- Astellas Pharma Europe Ltd.
- Target Recruit Count
- 12
- Registration Number
- NCT01775397
- Locations
- 🇪🇸
H.U. Gregorio Maranon, Madrid, Spain
🇩🇪Universitätsklinikum, Essen, Germany
🇩🇪Charité, Berlin, Germany
Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001)
- Conditions
- Interventions
- First Posted Date
- 2012-09-24
- Last Posted Date
- 2018-09-18
- Target Recruit Count
- 611
- Registration Number
- NCT01691248
Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
- First Posted Date
- 2012-05-04
- Last Posted Date
- 2018-09-18
- Target Recruit Count
- 38
- Registration Number
- NCT01591863
Fidaxomicin to Prevent Clostridium Difficile Colonization
- Conditions
- Interventions
- First Posted Date
- 2012-03-13
- Last Posted Date
- 2014-05-28
- Lead Sponsor
- Washington University School of Medicine
- Registration Number
- NCT01552668
- Locations
- 🇺🇸
Washington University in St. Louis, St. Louis, Missouri, United States
Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)
- Conditions
- Interventions
- First Posted Date
- 2006-04-17
- Last Posted Date
- 2017-04-21
- Target Recruit Count
- 629
- Registration Number
- NCT00314951
Drug Development Updates
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