Clinical trials: Fidaxomicin
Clostridium Difficile
Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection
Fecal microbiota transplantation (FMT) has been very effective for patients who suffer from mild C diff infection (CDI) which recurs but it is unclear how effective FMT alone is in treating severe and fulminant CDI.
- Trial name
- NCT03760484
- Testing
- Fidaxomicin 200 mg, fecal microbiota transplantation (FMT)
- Where
- Canada
- Volunteers
- 4 people
- Sponsor
- University of Alberta
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)
C. Difficile, Diarrhea
Impact of Oral Antibiotic Treatment on C. Difficile
The overall aim is to characterize and to compare the extent and quantity of C. difficile stool shedding, perianal colonization and environmental contamination in patients who received oral fidaxomicin, oral metronidazole, or…
- Conditions
- C. Difficile, Diarrhea, Enterocolitis
- Trial name
- C-Diff (NCT02057198)
- Testing
- Fidaxomicin, Metronidazole, Vancomycin
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Duke University
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 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)
Clostridium Difficile Infection (CDI)
A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections
Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure in the treatment of CDI, as well as for recurrence of CDI.
- Trial name
- NCT02692651
- Testing
- Fidaxomicin, Vancomycin
- Where
- 2 sites in United States
- Volunteers
- 144 people
- Sponsor
- University of Michigan
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-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
Optimal Treatment for Recurrent Clostridium Difficile
The purpose of this study is to determine whether fidaxomicin and vancomycin followed by taper and pulse vancomycin treatment are superior to standard vancomycin treatment for the treatment of recurrent Clostridium difficile…
- Conditions
- Clostridium, Difficile, Fidaxomicin, Vancomycin
- Trial name
- OpTION (NCT02667418)
- Testing
- Fidaxomicin, Vancomycin with Taper/Pulse, Vancomycin
- Where
- 33 sites in United States, Puerto Rico
- Volunteers
- 308 people
- Sponsor
- VA Office of Research and Development
Clostridium Difficile Infection
Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection
This is a medical research study designed to look at the safety and efficacy of 30-day course of fidaxomicin for treatment of recurrent CDI (Clostridium difficile Infection).
- Trial name
- NCT02395848
- Testing
- Fidaxomicin
- Where
- Canada
- Volunteers
- 31 people
- Sponsor
- McMaster University
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 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)