Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001) (DEFLECT-1)
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ClinicalTrials.gov Identifier: NCT01691248 |
Recruitment Status
:
Completed
First Posted
: September 24, 2012
Results First Posted
: April 12, 2016
Last Update Posted
: May 1, 2017
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Tracking Information | |||||
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First Submitted Date ICMJE | September 19, 2012 | ||||
First Posted Date ICMJE | September 24, 2012 | ||||
Results First Submitted Date | March 11, 2016 | ||||
Results First Posted Date | April 12, 2016 | ||||
Last Update Posted Date | May 1, 2017 | ||||
Actual Study Start Date ICMJE | October 10, 2012 | ||||
Actual Primary Completion Date | March 18, 2015 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up. [ Time Frame: Up to 30 days post-treatment ] CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.
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Original Primary Outcome Measures ICMJE |
The occurrence of CDAD from start of study treatment up to 30 days post-treatment follow-up in HSCT subjects. [ Time Frame: 30 days post-treatment ] CDAD is defined as:
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Change History | Complete list of historical versions of study NCT01691248 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Occurrence of CDAD from start of study treatment up to 60 days post-treatment [ Time Frame: Up to 60 days post-treatment ] | ||||
Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001) | ||||
Official Title ICMJE | DEFLECT-1: A Phase 3b Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Demonstrate the Safety and Efficacy of Fidaxomicin for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation | ||||
Brief Summary | 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Clostridium Difficile-Associated Diarrhea (CDAD) | ||||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
611 | ||||
Original Estimated Enrollment ICMJE |
340 | ||||
Actual Study Completion Date | April 16, 2015 | ||||
Actual Primary Completion Date | March 18, 2015 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | Canada, United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01691248 | ||||
Other Study ID Numbers ICMJE | 5119-001 OPT-80-302 ( Other Identifier: Optimerpharma Study Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Optimer Pharmaceuticals LLC | ||||
Study Sponsor ICMJE | Optimer Pharmaceuticals LLC | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Optimer Pharmaceuticals LLC | ||||
Verification Date | March 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |