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CLINICAL TRIALS PROFILE FOR DIFICID

All Clinical Trials for DIFICID

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01552668 ↗	Fidaxomicin to Prevent Clostridium Difficile Colonization	Withdrawn	Centers for Disease Control and Prevention	Phase 4	2012-09-01	The purpose of this research study is to evaluate the effectiveness of an antibiotic called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NCT01552668 ↗	Fidaxomicin to Prevent Clostridium Difficile Colonization	Withdrawn	Washington University School of Medicine	Phase 4	2012-09-01	The purpose of this research study is to evaluate the effectiveness of an antibiotic called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.
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.
NCT01813448 ↗	A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects	Completed	Cubist Pharmaceuticals LLC	Phase 1	2013-02-01	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. This study will also compare the safety, tolerability and PK of single and multiple doses of fidaxomicin in healthy Japanese and Caucasian subjects.
NCT01813448 ↗	A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects	Completed	Astellas Pharma Global Development, Inc.	Phase 1	2013-02-01	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. This study will also compare the safety, tolerability and PK of single and multiple doses of fidaxomicin in healthy Japanese and Caucasian subjects.

Clinical Trial Conditions for DIFICID

Condition Name

Condition Name for DIFICID
Intervention	Trials
Clostridium Difficile	3
Clostridium Difficile Infection	3
Clostridium Difficile-Associated Diarrhea (CDAD)	2
Healthy Subjects	1

Condition MeSH

Condition MeSH for DIFICID
Intervention	Trials
Clostridium Infections	8
Diarrhea	3
Infections	3
Infection	3

Clinical Trial Locations for DIFICID

Trials by Country

Trials by Country for DIFICID
Location	Trials
United States	22
Canada	7
Poland	5
Romania	4
France	3

Trials by US State

Trials by US State for DIFICID
Location	Trials
North Carolina	2
California	2
Missouri	2
Texas	2
Nebraska	1

Clinical Trial Progress for DIFICID

Clinical Trial Phase

Clinical Trial Phase for DIFICID
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for DIFICID
Clinical Trial Phase	Trials
Completed	6
Recruiting	2
Withdrawn	1

Clinical Trial Sponsors for DIFICID

Sponsor Name

Sponsor Name for DIFICID
Sponsor	Trials
Cubist Pharmaceuticals LLC	2
Merck Sharp & Dohme Corp.	2
University of Alberta	1

Sponsor Type

Sponsor Type for DIFICID
Sponsor	Trials
Industry	9
Other	6
U.S. Fed	1