CLINICAL TRIALS PROFILE FOR DIFICID
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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| NCT01552668 ↗ | Fidaxomicin to Prevent Clostridium Difficile Colonization | Withdrawn | Centers for Disease Control and Prevention | Phase 4 | 2012-09-01 | The purpose of this research study is to evaluate the effectiveness of an antibiotic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| NCT01552668 ↗ | Fidaxomicin to Prevent Clostridium Difficile Colonization | Withdrawn | Washington University School of Medicine | Phase 4 | 2012-09-01 | The purpose of this research study is to evaluate the effectiveness of an antibiotic called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. |
| NCT02057198 ↗ | Impact of Oral Antibiotic Treatment on C. Difficile | Completed | Duke University | Phase 4 | 2014-06-10 | 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 oral vancomycin. This is a prospective, randomized, microbiologic and molecular, study of environmental contamination from patients with proven C. difficile associated diarrhea (CDAD). |
| NCT02214771 ↗ | Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients | Completed | Astellas Pharma S.A.S. | 2014-09-03 | The study aims to describe the characteristics and the methods of management and follow-up of patients treated with fidaxomicin for Clostridium difficile infection (CDI). | |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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