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Last Updated: December 1, 2021

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CLINICAL TRIALS PROFILE FOR FIDAXOMICIN

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All Clinical Trials for fidaxomicin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00314951 ↗ Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018) Completed Optimer Pharmaceuticals LLC Phase 3 2006-05-02 This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).
NCT00468728 ↗ PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) Completed Optimer Pharmaceuticals LLC Phase 3 2006-10-04 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).
NCT01552668 ↗ Fidaxomicin to Prevent Clostridium Difficile Colonization Withdrawn Centers for Disease Control and Prevention Phase 4 2012-09-01 The purpose of this research study is to evaluate the effectiveness of an antibiotic called fidaxomicin in preventing C. difficile infection.
NCT01552668 ↗ Fidaxomicin to Prevent Clostridium Difficile Colonization Withdrawn Washington University School of Medicine Phase 4 2012-09-01 The purpose of this research study is to evaluate the effectiveness of an antibiotic called fidaxomicin in preventing C. difficile infection.
NCT01591863 ↗ Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD) Completed Optimer Pharmaceuticals LLC Phase 2 2012-06-15 The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).
NCT01691248 ↗ Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001) Completed Optimer Pharmaceuticals LLC Phase 3 2012-10-10 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 transplantation (HSCT). The primary hypothesis is that Fidaxomicin is superior to placebo in preventing CDAD in participants undergoing HSCT.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for fidaxomicin

Condition Name

Condition Name for fidaxomicin
Intervention Trials
Clostridium Difficile Infection 10
Clostridium Difficile 6
Diarrhea 4
Clostridium Infections 3
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Condition MeSH

Condition MeSH for fidaxomicin
Intervention Trials
Clostridium Infections 27
Infections 16
Infection 15
Enterocolitis, Pseudomembranous 13
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Clinical Trial Locations for fidaxomicin

Trials by Country

Trials by Country for fidaxomicin
Location Trials
United States 133
Canada 17
United Kingdom 8
Poland 7
France 6
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Trials by US State

Trials by US State for fidaxomicin
Location Trials
California 8
New York 7
North Carolina 6
Massachusetts 6
Illinois 6
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Clinical Trial Progress for fidaxomicin

Clinical Trial Phase

Clinical Trial Phase for fidaxomicin
Clinical Trial Phase Trials
Phase 4 13
Phase 3 8
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for fidaxomicin
Clinical Trial Phase Trials
Completed 17
Recruiting 6
Terminated 4
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Clinical Trial Sponsors for fidaxomicin

Sponsor Name

Sponsor Name for fidaxomicin
Sponsor Trials
Optimer Pharmaceuticals LLC 5
Merck Sharp & Dohme Corp. 4
Cubist Pharmaceuticals LLC 4
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Sponsor Type

Sponsor Type for fidaxomicin
Sponsor Trials
Other 33
Industry 25
U.S. Fed 2
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