Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Shire

ClinicalTrials.gov Identifier:

NCT01259726

First received: December 9, 2010

Last updated: February 11, 2015

Last verified: March 2014

History of Changes

Results First Received: January 20, 2015

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Clostridium Difficile Infection
Interventions:	Biological: VP20621 Other: 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
This study was conducted at a total of 44 investigative sites [United states (US)=33, Canada=4, and Europe=7], and 3 of the 33 US sites did not enroll any participants (each had 1 screen failure).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 213 participants formally screened to participate in this study, 168 participants were treated. Five participants were randomized but not treated and 40 participants were screen failures.

Reporting Groups

	Description
Placebo	Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
VP 20621 Low Dose and Placebo	VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
VP 20621 High Dose and Placebo	VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
VP 20621 High Dose	VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.

Participant Flow: Overall Study

	Placebo	VP 20621 Low Dose and Placebo	VP 20621 High Dose and Placebo	VP 20621 High Dose
STARTED	43	41	43	41
Treated	40	37	41	39
COMPLETED	38	37	39	36
NOT COMPLETED	5	4	4	5
Death	1	0	0	0
Physician Decision	2	0	1	1
Withdrawal by Subject	1	3	2	1
Lost to Follow-up	1	1	1	3

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.
Intent-to-Treat-Safety (ITT-S) population was defined as all randomized participants who received at least 1 dose of study drug.

Reporting Groups

	Description
Placebo	Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
VP 20621 Low Dose and Placebo	VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
VP 20621 High Dose and Placebo	VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
VP 20621 High Dose	VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
Total	Total of all reporting groups

Baseline Measures

	Placebo	VP 20621 Low Dose and Placebo	VP 20621 High Dose and Placebo	VP 20621 High Dose	Total
Overall Participants Analyzed [Units: Participants]	43	41	43	41	168

Age [Units: Years] Mean (Standard Deviation)	54.7 (19.19)	58.2 (14.42)	57.2 (18.46)	60.6 (16.4)	57.6 (17.2)

Gender [Units: Participants]
Female	26	26	24	28	104
Male	17	15	19	13	64

Outcome Measures

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1. Primary:

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 7 days after the last dose of study drug (up to Week 3) ]

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2. Primary:

Number of Participants With Positive Clostridium Difficile Stool Cultures Demonstrating Non-Toxigenic Clostridium Difficile-Strain M3 [ Time Frame: After study drug administration period (14 days) through Week 6 ]

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3. Secondary:

Number of Participants With Clostridium Difficile Infection (CDI) Recurrence [ Time Frame: Baseline (Day 1) up to Week 6 ]

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4. Secondary:

Number of Participants With Use of Antibacterial Treatment for CDI [ Time Frame: Baseline (Day 1) up to Week 6 ]

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5. Secondary:

Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools [ Time Frame: Baseline (Day 1) up to Week 6 ]

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6. Secondary:

Time to First CDI Recurrence [ Time Frame: Baseline (Day 1) up to Week 6 ]

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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: If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.

Results Point of Contact:

Name/Title: Study Physician
Organization: Shire
phone: 1 866-842-5335

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

Gerding DN, Meyer T, Lee C, Cohen SH, Murthy UK, Poirier A, Van Schooneveld TC, Pardi DS, Ramos A, Barron MA, Chen H, Villano S. Administration of spores of nontoxigenic Clostridium difficile strain M3 for prevention of recurrent C. difficile infection: a randomized clinical trial. JAMA. 2015 May 5;313(17):1719-27. doi: 10.1001/jama.2015.3725.

Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01259726 History of Changes
Other Study ID Numbers:	VP20621-200 2010-020484-20 ( EudraCT Number )
Study First Received:	December 9, 2010
Results First Received:	January 20, 2015
Last Updated:	February 11, 2015

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