Clinical trials: Fidaxomicin
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)
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 Difficile Infection
Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?
This study evaluates whether patients with Clostridium difficile infection (CDI) who are treated with fidaxomicin have less contamination of their skin and surrounding environment with spores of C.
- Trial name
- NCT02461901
- Testing
- Environmental sampling, Skin swab sampling, Fecal sampling
- Where
- 3 sites in United Kingdom
- Volunteers
- 203 people
- Sponsor
- Professor Mark Wilcox
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.
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
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-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
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
Clostridium Difficile, Spinal Cord Injury
Use Of Oral Fidaxomicin Vs. Oral Vancomycin For Clostridium Difficile Infection In Patients With Spinal Cord Injury
The primary purpose of this study is to compare the clinical outcomes of cure and recurrence of Clostridium difficile infection in spinal cord injured patients who are treated with oral Fidaxomicin vs. oral Vancomycin.
- Trial name
- NCT02355938
- Testing
- Fidaxomicin 200 mg, Vancomycin
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Baylor College of Medicine
Clostridioides Difficile Infection, Clostridioides Difficile Infection Recurrence
STOP-CDI: Efficacy of Fecal Microbiota Transplantation vs Fidaxomicin vs Vancomycin in Treating and Preventing Relapse of Clostridioides Difficile Infection
The STOP-CDI study is a multicenter, randomized, open-label, three-arm clinical trial comparing the efficacy of fecal microbiota transplantation (FMT) preceded by vancomycin, fidaxomicin monotherapy, and standard-of-care…
- Conditions
- Clostridioides Difficile Infection, Clostridioides Difficile Infection Recurrence, Fecal Microbiota Transplantation (FMT), Comparative Effectiveness of CDI Treatments
- Trial name
- STOP-CDI (NCT07120490)
- Testing
- FMT (fecal microbiota transplantation), Fidaxomicin, Vancomycin (VAN) treatment
- Volunteers
- 424 people
- Sponsor
- Medical University of Warsaw
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)
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 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
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
Clostridium Difficile Infection (CDI)
Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI)
This is a single center collection of discarded biological samples and electronic medical review (EMR) data on patients who are hospitalized with clostridium difficile infections and treated with Fidaxomicin
- Trial name
- NCT04070352
- Testing
- Fidaxomicin
- Where
- United States
- Sponsor
- University of Pittsburgh
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
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
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.