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

May 30, 2021 updated by: Shire

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aalst, Belgium
      • Brussels, Belgium
      • Leuven, Belgium
      • Liege, Belgium
    • Alberta
      • Calgary, Alberta, Canada
    • Ontario
      • Hamilton, Ontario, Canada
    • Quebec
      • Chicoutimi, Quebec, Canada
      • Montreal, Quebec, Canada
      • Trois-Rivieres, Quebec, Canada
      • Hannover, Germany
      • Koln, Germany
      • Leipzig, Germany
      • Wilhelmshaven, Germany
    • Andalucia
      • Sevilla, Andalucia, Spain
    • Cataluna
      • Barcelona, Cataluna, Spain
    • Communidad De Madrid
      • Majadahonda, Communidad De Madrid, Spain
      • Lugano, Switzerland
    • California
      • Modesto, California, United States
      • Palm Desert, California, United States
      • Sacramento, California, United States
    • Colorado
      • Aurora, Colorado, United States
    • Connecticut
      • Hartford, Connecticut, United States
    • Florida
      • Bay Pines, Florida, United States
      • Jacksonville, Florida, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Illinois
      • Chicago, Illinois, United States
      • Maywood, Illinois, United States
    • Indiana
      • Anderson, Indiana, United States
      • Lafayette, Indiana, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Maryland
      • Chevy Chase, Maryland, United States
    • Michigan
      • Detroit, Michigan, United States
      • Grosse Pointe Woods, Michigan, United States
      • Novi, Michigan, United States
      • Royal Oak, Michigan, United States
      • Sault Sainte-Marie, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • Montana
      • Butte, Montana, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New York
      • Albany, New York, United States
      • Bronx, New York, United States
      • New York, New York, United States
      • North Massapequa, New York, United States
      • Syracuse, New York, United States
    • North Carolina
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Cleveland, Ohio, United States
      • Lima, Ohio, United States
      • Toledo, Ohio, United States
    • Pennsylvania
      • Lancaster, Pennsylvania, United States
      • West Reading, Pennsylvania, United States
    • Tennessee
      • Memphis, Tennessee, United States
    • Texas
      • Houston, Texas, United States
      • Temple, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Winchester, Virginia, United States
    • Washington
      • Tacoma, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
10 mL placebo once daily for 14 days
Experimental: VP20621 Low Dose and Placebo
10 mL placebo once daily for 14 days
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days
VP20621 as oral liquid once daily for 14 days
Experimental: VP20621 High Dose and Placebo
10 mL placebo once daily for 14 days
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days
VP20621 as oral liquid once daily for 14 days
Experimental: VP20621 High Dose
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days
VP20621 as oral liquid once daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
Baseline up to 7 days after the last dose of study drug (up to Week 3)
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
After study drug administration period (14 days) through Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clostridium Difficile Infection (CDI) Recurrence
Time Frame: Baseline (Day 1) up to Week 6
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.
Baseline (Day 1) up to Week 6
Number of Participants With Use of Antibacterial Treatment for CDI
Time Frame: Baseline (Day 1) up to Week 6
Any antibacterial medication used after Day 1 for which the investigator selected the indication "antibacterial for C. difficile infection".
Baseline (Day 1) up to Week 6
Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools
Time Frame: Baseline (Day 1) up to Week 6
Data were derived from all AEs starting on or after Day 1 for which a Diarrhea CRF page was completed.
Baseline (Day 1) up to Week 6
Time to First CDI Recurrence
Time Frame: Baseline (Day 1) up to Week 6
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.
Baseline (Day 1) up to Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2011

Primary Completion (Actual)

June 11, 2013

Study Completion (Actual)

June 11, 2013

Study Registration Dates

First Submitted

December 9, 2010

First Submitted That Met QC Criteria

December 10, 2010

First Posted (Estimate)

December 14, 2010

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

May 30, 2021

Last Verified

May 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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