Clinical trials: Fidaxomicin
Clostridium Difficile
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
The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive therapy.
- Trial name
- FREEDOM (NCT01775397)
- Testing
- Fidaxomicin, Vancomycin
- Where
- 16 sites in Austria, Denmark and 5 more
- Volunteers
- 12 people
- Sponsor
- Astellas Pharma Europe Ltd.
Clostridium Infections, Diarrhea
PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- NCT00468728
- Testing
- PAR-101/OPT-80, Vancomycin
- Where
- 116 sites in United States, Belgium and 7 more
- Volunteers
- 535 people
- Sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Drug-Drug Interaction (DDI), Intestinal Absorption
A Study to Assess the Effects of Multiple Doses of Fidaxomicin on a Single Dose of Rosuvastatin in Healthy Male Subjects
This study will assess the effect of multiple doses of fidaxomicin on the single dose pharmacokinetics of rosuvastatin in healthy male subjects.
- Conditions
- Drug-Drug Interaction (DDI), Intestinal Absorption, Healthy Subjects, Pharmacokinetics of Rosuvastatin
- Trial name
- NCT02083627
- Testing
- rosuvastatin, fidaxomicin
- Where
- Germany
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Clostridium Difficile-Associated Diarrhea (CDAD)
Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001)
The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult participants undergoing hematopoietic stem cell…
- Trial name
- DEFLECT-1 (NCT01691248)
- Testing
- fidaxomicin
- Volunteers
- 611 people
- Sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Clostridium Difficile-associated Diarrhea
Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- NCT01591863
- Testing
- fidaxomicin
- Volunteers
- 38 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.
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-associated Diarrhea (CDAD)
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)
The purpose of this study was to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- SUNSHINE (NCT02218372)
- Testing
- Fidaxomicin oral suspension, Fidaxomicin tablets, Vancomycin oral liquid
- Where
- 44 sites in United States, Belgium and 8 more
- Volunteers
- 148 people
- Sponsor
- Astellas Pharma Europe B.V.
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 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)
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.
Recurrent Clostridium Difficile Infection, Primary Clostridium Difficile Infection
Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin
Patients with microbiota alterations developed after being exposed to antibiotics are especially susceptible to Clostridioides difficile infections (CDI).
- Trial name
- NCT05201079
- Testing
- MBK-01, Fidaxomicin
- Where
- 21 sites in Spain
- Volunteers
- 93 people
- Sponsor
- Mikrobiomik Healthcare Company S.L.
Clostridium Difficile Infection
A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)
The purpose of this research study is to evaluate the safety and effectiveness of Ridinilazole (SMT19969) in treating C. difficile Infection (CDI).
- Trial name
- NCT02784002
- Testing
- Ridinilazole, Fidaxomicin
- Where
- 16 sites in United States, Czechia and 1 more
- Volunteers
- 27 people
- Sponsor
- Summit Therapeutics
Clostridium Difficile
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
The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day…
- Trial name
- EXTEND (NCT02254967)
- Testing
- Fidaxomicin, Vancomycin
- Where
- 109 sites in Austria, Belgium and 20 more
- Volunteers
- 364 people
- Sponsor
- Astellas Pharma Europe Ltd.
Clostridium Difficile
A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
The primary objective of this study is to investigate the safety and efficacy of OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- NCT02179658
- Testing
- OPT-80, vancomycin
- Where
- 7 sites in Japan
- Volunteers
- 210 people
- Sponsor
- Astellas Pharma Inc