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

Primary Purpose

Clostridium Difficile Infection

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VP20621
VP20621
Placebo
VP20621
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile Infection focused on measuring Diarrhea, Clostridium difficile, Clostridium infections, Signs and Symptoms Digestive, Bacterial Infections, Pharmacologic Actions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult subjects, 18 years of age and over, who understand the risks and benefits of participation and have provided written informed consent for the study.
  2. Subjects who are experiencing a first event or first recurrence of clostridium difficile (CDI) within the last 28 days and have been successfully treated with an antibiotic for CDI.
  3. Subjects who are medically stable.
  4. Subjects who are willing and able to comply with the study procedures and visit schedules outlined.
  5. If female be post-menopausal, surgically sterile or agree to follow an acceptable method of birth control.

Exclusion Criteria:

  1. Subjects who have had more than 2 episodes of CDI within the last 6 months.
  2. Subjects who have been diagnosed with Inflammatory Bowel Disease,active Irritable Bowel Syndrome, celiac disease, active gastroparesis, toxic megacolon.
  3. GI surgery within 6 weeks before the day of randomization
  4. Have known immunodeficiency disorder, such as HIV Infection
  5. Pregnant or breast feeding females.
  6. Concurrent acute life-threatening diseases.
  7. Inability to tolerate oral liquids.
  8. Have an absolute neutrophil count < 1000/mm3 at screening

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

VP20621 Low Dose and Placebo

VP20621 High Dose and Placebo

VP20621 High Dose

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a study participant, regardless of causal relationship. TEAEs were defined as all AEs that start during the study drug treatment period (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during the study drug treatment period (and up to 7 days after the last dose of study drug). SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement.
Number of Participants With Positive Clostridium Difficile Stool Cultures Demonstrating Non-Toxigenic Clostridium Difficile-Strain M3

Secondary Outcome Measures

Number of Participants With Clostridium Difficile Infection (CDI) Recurrence
CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea case report form (CRF) page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator.
Number of Participants With Use of Antibacterial Treatment for CDI
Any antibacterial medication used after Day 1 for which the investigator selected the indication "antibacterial for C. difficile infection".
Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools
Data were derived from all AEs starting on or after Day 1 for which a Diarrhea CRF page was completed.
Time to First CDI Recurrence
CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea CRF page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator. Time of onset is from date of randomization to date of first CDI recurrence. Time to first CDI recurrence was assessed using Kaplan-Meier curve. Due to small number of subjects (<50%) with CDI recurrence, median time to event was not evaluable.

Full Information

First Posted
December 9, 2010
Last Updated
May 30, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01259726
Brief Title
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of VP 20621 for Prevention of Recurrence of Clostridium Difficile Infection (CDI) in Adults Previously Treated for CDI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 27, 2011 (Actual)
Primary Completion Date
June 11, 2013 (Actual)
Study Completion Date
June 11, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a dose regimen of VP 20621 to be used in future studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection
Keywords
Diarrhea, Clostridium difficile, Clostridium infections, Signs and Symptoms Digestive, Bacterial Infections, Pharmacologic Actions

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
VP20621 Low Dose and Placebo
Arm Type
Experimental
Arm Title
VP20621 High Dose and Placebo
Arm Type
Experimental
Arm Title
VP20621 High Dose
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
VP20621
Intervention Description
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days
Intervention Type
Biological
Intervention Name(s)
VP20621
Intervention Description
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
10 mL placebo once daily for 14 days
Intervention Type
Biological
Intervention Name(s)
VP20621
Intervention Description
VP20621 as oral liquid once daily for 14 days
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a study participant, regardless of causal relationship. TEAEs were defined as all AEs that start during the study drug treatment period (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during the study drug treatment period (and up to 7 days after the last dose of study drug). SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement.
Time Frame
Baseline up to 7 days after the last dose of study drug (up to Week 3)
Title
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
Secondary Outcome Measure Information:
Title
Number of Participants With Clostridium Difficile Infection (CDI) Recurrence
Description
CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea case report form (CRF) page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator.
Time Frame
Baseline (Day 1) up to Week 6
Title
Number of Participants With Use of Antibacterial Treatment for CDI
Description
Any antibacterial medication used after Day 1 for which the investigator selected the indication "antibacterial for C. difficile infection".
Time Frame
Baseline (Day 1) up to Week 6
Title
Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools
Description
Data were derived from all AEs starting on or after Day 1 for which a Diarrhea CRF page was completed.
Time Frame
Baseline (Day 1) up to Week 6
Title
Time to First CDI Recurrence
Description
CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea CRF page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator. Time of onset is from date of randomization to date of first CDI recurrence. Time to first CDI recurrence was assessed using Kaplan-Meier curve. Due to small number of subjects (<50%) with CDI recurrence, median time to event was not evaluable.
Time Frame
Baseline (Day 1) up to Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult subjects, 18 years of age and over, who understand the risks and benefits of participation and have provided written informed consent for the study. Subjects who are experiencing a first event or first recurrence of clostridium difficile (CDI) within the last 28 days and have been successfully treated with an antibiotic for CDI. Subjects who are medically stable. Subjects who are willing and able to comply with the study procedures and visit schedules outlined. If female be post-menopausal, surgically sterile or agree to follow an acceptable method of birth control. Exclusion Criteria: Subjects who have had more than 2 episodes of CDI within the last 6 months. Subjects who have been diagnosed with Inflammatory Bowel Disease,active Irritable Bowel Syndrome, celiac disease, active gastroparesis, toxic megacolon. GI surgery within 6 weeks before the day of randomization Have known immunodeficiency disorder, such as HIV Infection Pregnant or breast feeding females. Concurrent acute life-threatening diseases. Inability to tolerate oral liquids. Have an absolute neutrophil count < 1000/mm3 at screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Modesto
State/Province
California
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United States
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Palm Desert
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California
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Sacramento
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Aurora
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Colorado
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Hartford
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Connecticut
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Bay Pines
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Jacksonville
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Honolulu
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Chicago
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Maywood
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Anderson
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Lafayette
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Lexington
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New Orleans
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Louisiana
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Chevy Chase
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Maryland
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Detroit
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Grosse Pointe Woods
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Michigan
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Novi
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Royal Oak
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Sault Sainte-Marie
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Rochester
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Saint Louis
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Butte
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Omaha
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Nebraska
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Albany
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New York
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Bronx
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New York
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New York
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New York
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North Massapequa
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Syracuse
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Winston-Salem
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North Carolina
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Akron
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Ohio
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Cleveland
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Lima
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Toledo
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Lancaster
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Pennsylvania
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West Reading
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Memphis
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Tennessee
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Houston
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Temple
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Salt Lake City
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Utah
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Winchester
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Virginia
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Tacoma
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Aalst
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Belgium
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Brussels
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Belgium
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Leuven
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Belgium
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Liege
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Belgium
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Calgary
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Alberta
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Hamilton
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Ontario
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Chicoutimi
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Montreal
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Trois-Rivieres
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Quebec
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Hannover
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Germany
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Koln
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Germany
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Leipzig
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Germany
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Wilhelmshaven
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Germany
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Sevilla
State/Province
Andalucia
Country
Spain
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Barcelona
State/Province
Cataluna
Country
Spain
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Majadahonda
State/Province
Communidad De Madrid
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Spain
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Lugano
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25942722
Citation
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.
Results Reference
derived

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

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