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

NCT01259726 | Completed Phase 2 Results DMC

• 2 other identifiers: VP20621-2002010-020484-20
• Study Type: interventional
• Target: 173
• Locations: 6 countries
• Sites: 59

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.

Conditions

Clostridium Difficile Infection

Keywords

Diarrhea; Clostridium difficile; Clostridium infections; Signs and Symptoms Digestive; Bacterial Infections; Pharmacologic Actions

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  After study drug administration period (14 days) through Week 6

Secondary Outcomes (4)

• Number of Participants With Clostridium Difficile Infection (CDI) Recurrence

  Baseline (Day 1) up to Week 6

• Number of Participants With Use of Antibacterial Treatment for CDI

  Baseline (Day 1) up to Week 6

• Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools

  Baseline (Day 1) up to Week 6

• Time to First CDI Recurrence

  Baseline (Day 1) up to Week 6

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Other: Placebo

VP20621 Low Dose and Placebo

EXPERIMENTAL

Biological: VP20621; Other: Placebo

VP20621 High Dose and Placebo

EXPERIMENTAL

Biological: VP20621; Other: Placebo

VP20621 High Dose

EXPERIMENTAL

Biological: VP20621

Interventions

VP20621 BIOLOGICAL

VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days

VP20621 Low Dose and Placebo

Placebo OTHER

10 mL placebo once daily for 14 days

Placebo; VP20621 High Dose and Placebo; VP20621 Low Dose and Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shire: lead

Study Sites (59)

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Modesto, California, United States

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Palm Desert, California, United States

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Sacramento, California, United States

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Aurora, Colorado, United States

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Hartford, Connecticut, United States

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Bay Pines, Florida, United States

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Jacksonville, Florida, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Maywood, Illinois, United States

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Anderson, Indiana, United States

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Lafayette, Indiana, United States

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Lexington, Kentucky, United States

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New Orleans, Louisiana, United States

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Chevy Chase, Maryland, United States

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Detroit, Michigan, United States

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Grosse Pointe Woods, Michigan, United States

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Novi, Michigan, United States

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Royal Oak, Michigan, United States

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Sault Ste. Marie, Michigan, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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Butte, Montana, United States

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Omaha, Nebraska, United States

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Albany, New York, United States

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New York, New York, United States

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North Massapequa, New York, United States

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Syracuse, New York, United States

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The Bronx, New York, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Cleveland, Ohio, United States

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Lima, Ohio, United States

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Toledo, Ohio, United States

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Lancaster, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Memphis, Tennessee, United States

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Houston, Texas, United States

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Temple, Texas, United States

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Salt Lake City, Utah, United States

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Winchester, Virginia, United States

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Tacoma, Washington, United States

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Aalst, Belgium

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Brussels, Belgium

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Leuven, Belgium

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Liège, Belgium

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Calgary, Alberta, Canada

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Hamilton, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Montreal, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Cologne, Germany

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Hanover, Germany

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Leipzig, Germany

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Wilhelmshaven, Germany

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Seville, Andalusia, Spain

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Barcelona, Catalonia, Spain

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Majadahonda, Communidad de Madrid, Spain

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Lugano, Switzerland

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Related Publications (1)

• 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.

  PMID: 25942722 DERIVED

MeSH Terms

Conditions

Clostridium Infections; Diarrhea; Signs and Symptoms, Digestive; Bacterial Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections and Mycoses; Infections; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 14, 2010
• Study Start: June 27, 2011
• Primary Completion: June 11, 2013
• Study Completion: June 11, 2013
• Last Updated: June 10, 2021
• Results First Posted: February 12, 2015

Record last verified: 2021-05

Locations

BE (4); US (42); CH (1); DE (4); CA (5); ES (3)