Clinical trial NCT01259726: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clostridium Difficile Infection
Keywords: Diarrhea
Clostridium difficile
Clostridium infections
Signs and Symptoms Digestive
Bacterial Infections
Pharmacologic Actions
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-12-14
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 7 days after the last dose of study drug (up to Week 3)
measure: Number of Participants With Positive Clostridium Difficile Stool Cultures Demonstrating Non-Toxigenic Clostridium Difficile-Strain M3
timeFrame: After study drug administration period (14 days) through Week 6
Secondary outcomes:
measure: Number of Participants With Clostridium Difficile Infection (CDI) Recurrence
timeFrame: Baseline (Day 1) up to Week 6
measure: Number of Participants With Use of Antibacterial Treatment for CDI
timeFrame: Baseline (Day 1) up to Week 6
measure: Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools
timeFrame: Baseline (Day 1) up to Week 6
measure: Time to First CDI Recurrence
timeFrame: Baseline (Day 1) up to Week 6
Other outcomes:
Locations:
city: Modesto
country: United States
state: California
city: Palm Desert
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
city: Bay Pines
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Anderson
country: United States
state: Indiana
city: Lafayette
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Chevy Chase
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Grosse Pointe Woods
country: United States
state: Michigan
city: Novi
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Sault Sainte-Marie
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Butte
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Albany
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: North Massapequa
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Lima
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Lancaster
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Winchester
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
city: Aalst
country: Belgium
city: Brussels
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Hamilton
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Trois-Rivieres
country: Canada
state: Quebec
city: Hannover
country: Germany
city: Koln
country: Germany
city: Leipzig
country: Germany
city: Wilhelmshaven
country: Germany
city: Sevilla
country: Spain
state: Andalucia
city: Barcelona
country: Spain
state: Cataluna
city: Majadahonda
country: Spain
state: Communidad De Madrid
city: Lugano
country: Switzerland
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
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.