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Last Updated: November 22, 2024

CLINICAL TRIALS PROFILE FOR FIDAXOMICIN

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All Clinical Trials for FIDAXOMICIN

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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NCT01552668 ↗	Fidaxomicin to Prevent Clostridium Difficile Colonization	Withdrawn	Centers for Disease Control and Prevention	Phase 4	2012-09-01	The purpose of this research study is to evaluate the effectiveness of an antibiotic called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NCT01552668 ↗	Fidaxomicin to Prevent Clostridium Difficile Colonization	Withdrawn	Washington University School of Medicine	Phase 4	2012-09-01	The purpose of this research study is to evaluate the effectiveness of an antibiotic called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	>Sponsor	>Phase	>Start Date	>Summary

Clinical Trial Conditions for FIDAXOMICIN

Condition Name

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Condition Name for FIDAXOMICIN
Intervention	Trials
Clostridium Difficile Infection	10
Clostridium Difficile	6
Diarrhea	4
Clostridium Difficile Infection Recurrence	3
[disabled in preview]	0
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Condition MeSH

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Condition MeSH for FIDAXOMICIN
Intervention	Trials
Clostridium Infections	31
Infections	20
Communicable Diseases	15
Infection	15
[disabled in preview]	0
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Clinical Trial Locations for FIDAXOMICIN

Trials by Country

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

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Trials by US State for FIDAXOMICIN
Location	Trials
California	8
New York	7
Illinois	6
Utah	6
Texas	6
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Clinical Trial Progress for FIDAXOMICIN

Clinical Trial Phase

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Clinical Trial Phase for FIDAXOMICIN
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	11
Phase 2	6
[disabled in preview]	5
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Clinical Trial Status

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Clinical Trial Status for FIDAXOMICIN
Clinical Trial Phase	Trials
Completed	17
Recruiting	7
Not yet recruiting	4
[disabled in preview]	8
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Clinical Trial Sponsors for FIDAXOMICIN

Sponsor Name

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Sponsor Name for FIDAXOMICIN
Sponsor	Trials
Optimer Pharmaceuticals LLC	5
Cubist Pharmaceuticals LLC	4
Merck Sharp & Dohme Corp.	4
[disabled in preview]	6
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Sponsor Type

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Sponsor Type for FIDAXOMICIN
Sponsor	Trials
Other	36
Industry	26
U.S. Fed	2
[disabled in preview]	1
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