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)

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
Condition:	Clostridium Difficile-Associated Diarrhea (CDAD)
Interventions:	Drug: fidaxomicin; Drug: Placebo

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Fidaxomicin	200 mg Fidaxomicin tablet once daily for no longer than 40 days
Placebo	Placebo tablet once daily for no longer than 40 days

Participant Flow:   Overall Study

	Fidaxomicin	Placebo
STARTED	305 [1]	306 [1]
Treated	301 [2]	299 [2]
Safety Analysis Set	300 [3]	300 [3]
COMPLETED	194	192
NOT COMPLETED	111	114
Protocol Violation	43	27
Adverse Event	24	22
Withdrawal by Subject	20	18
Confirmed CDAD	14	31
Lost to Follow-up	2	5
Reason not provided	4	4
Not Treated	4	7

[1]	Randomized
[2]	Received at least 1 dose of study drug
[3]	A participant randomized to Fidaxomicin, received placebo instead.

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified Intent-to-Treat (mITT) consisting of all randomized participants undergoing hematopoietic stem cell transplantation (HSCT) who received at least 1 dose of study drug.

Reporting Groups

	Description
Fidaxomicin	200 mg Fidaxomicin tablet once daily for no longer than 40 days
Placebo	Placebo tablet once daily for no longer than 40 days
Total	Total of all reporting groups

Baseline Measures

	Fidaxomicin	Placebo	Total
Overall Participants Analyzed; [Units: Participants]	301	299	600
Age; [Units: Years]; Mean (Standard Deviation)	55.1 (12.00)	55.1 (13.23)	55.1 (12.62)
Sex: Female, Male; [Units: Participants]; Count of Participants
Female	125 41.5%	103 34.4%	228 38.0%
Male	176 58.5%	196 65.6%	372 62.0%

  Outcome Measures

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1. Primary:

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 ]

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2. Secondary:

Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment. [ Time Frame: Up to 60 days post-treatment ]

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3. Secondary:

Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to Day 70 of Study. [ Time Frame: Up to Day 70 of study ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is: The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: Any publication or other public presentation of results from this study requires prior review and written approval of the Sponsor. Draft abstracts, manuscripts, and materials for presentation at scientific meetings should be provided to the Sponsor at least 90 working days prior to abstract or other relevant submission deadlines.

Results Point of Contact:  

Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mullane KM, Winston DJ, Nooka A, Morris MI, Stiff P, Dugan MJ, Holland H, Gregg K, Adachi JA, Pergam SA, Alexander BD, Dubberke ER, Broyde N, Gorbach SL, Sears PS. A Randomized, Placebo-Controlled Trial of Fidaxomicin for Prophylaxis of Clostridium difficile Associated Diarrhea in Adults undergoing Hematopoietic Stem Cell Transplantation. Clin Infect Dis. 2018 Jun 9. doi: 10.1093/cid/ciy484. [Epub ahead of print]

Responsible Party:	Optimer Pharmaceuticals LLC
ClinicalTrials.gov Identifier:	NCT01691248 History of Changes
Other Study ID Numbers:	5119-001; OPT-80-302 ( Other Identifier: Optimerpharma Study Number )
First Submitted:	September 19, 2012
First Posted:	September 24, 2012
Results First Submitted:	March 11, 2016
Results First Posted:	April 12, 2016
Last Update Posted:	May 1, 2017