Clinical trials: Fidaxomicin
Pharmacokinetics of Fidaxomicin, Healthy Subjects
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of fidaxomicin in healthy subjects.
- Trial name
- NCT01813448
- Testing
- Fidaxomicin
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Clostridium Difficile Infection
Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients
The study aims to describe the characteristics and the methods of management and follow-up of patients treated with fidaxomicin for Clostridium difficile infection (CDI).
- Trial name
- DAFNE (NCT02214771)
- Testing
- Fidaxomicin, Treatment for CDI other than fidaxomicin Type
- Where
- 24 sites in France
- Volunteers
- 296 people
- Sponsor
- Astellas Pharma S.A.S.
Clostridium Difficile Infection
Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin
The purpose of this study is to compare number of vegetative cells and spores in stool over time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C. difficile infection.
- Trial name
- NCT01818141
- Testing
- Vancomycin, Fidaxomicin
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Hartford Hospital
Clostridium Difficile Infection, Solid Organ Transplant
Fidaxomicin Versus Standard of Care Therapy in Solid Organ Transplant Recipients With Clostridium Difficile Infection
A prospective study to assess the efficacy and safety of fidaxomicin in Solid Organ Transplant (SOT) recipients (heart, lung, kidney, liver, kidney-pancreas, and pancreas) with a first-episode of Clostridium difficile infection…
- Trial name
- NCT02464306
- Testing
- fidaxomicin
- Sponsor
- University of Colorado, Denver
Clostridioides Difficile Infection
Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence
The clinical trial aims to evaluate the efficacy of fecal microbiota transplantation (FMT) after standard of care treatment (either vancomycin or fidaxomicin) vs the pragmatic use of standard of care treatment (either vancomycin…
- Trial name
- FENDER (NCT05266807)
- Testing
- oral capsulized Fecal Microbiota Transplantation, Vancomycin or Fidaxomicin
- Where
- 8 sites in Switzerland
- Volunteers
- 100 people
- Sponsor
- Benoit Guery
Clostridium Infections, Diarrhea
Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)
This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).
- Trial name
- NCT00314951
- Testing
- Fidaxomicin, Vancomycin
- Volunteers
- 629 people
- Sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Clostridium Difficile
To Determine the Feasibility of a Fidaxomicin Study in Neonates and to Assess C. Difficile (Clostridium Difficile) Involvement in the Pathogenesis
The objective of this multi-center, prospective observational study is to determine the feasibility of a potential interventional study with fidaxomicin.
- Trial name
- DAISY (NCT01533844)
- Where
- 9 sites in France, Germany and 2 more
- Volunteers
- 1 people
- Sponsor
- Astellas Pharma Europe B.V.
Clostridium Difficile Infection
Fidaxomicin to Prevent Clostridium Difficile Colonization
The purpose of this research study is to evaluate the effectiveness of an antibiotic called fidaxomicin in preventing C. difficile infection.
- Trial name
- NCT01552668
- Testing
- Fidaxomicin
- Where
- United States
- Sponsor
- Washington University School of Medicine
Inflammatory Bowel Disease (IBD), Clostridium Difficile Infection (CDI)
Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)
The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection (CDI).
- Trial name
- PROFILE (NCT02437591)
- Testing
- fidaxomicin
- Where
- 12 sites in Austria, France and 5 more
- Volunteers
- 25 people
- Sponsor
- Astellas Pharma Europe Ltd.