Clinical trial NCT00106509: A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea
Official title: A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole, in Patients With C.Difficile - Associated Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Clostridium Enterocolitis
Pseudomembranous Colitis
Keywords: Clostridium Enterocolitis
Pseudomembranous Colitis
Clostridium difficile-associated diarrhea
C. difficile
CDAD
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-03-28
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Approximately 520 patients will be entered into this study taking place throughout the US and Canada. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 6 weeks.


Eligibility criteria: Inclusion Criteria:

* 18 years of age
* The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
* Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD
* Baseline serum potassium \> 3.0 mmol (meq)/L
* Patient considered sufficiently stable clinically to likely complete a 6 week study period

Primary outcomes:
measure: Resolution of diarrhea
Secondary outcomes:
measure: Time to resolution of diarrhea
measure: Recurrence rate
measure: Number of stools
measure: Average stool consistency
measure: Treatment success
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Rogers
country: United States
state: Arkansas
city: Burbank
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Modesto
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Newark
country: United States
state: Delaware
city: Bay Pines
country: United States
state: Florida
city: Brandon
country: United States
state: Florida
city: Brooksville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Zephyrhills
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Ft. Gordon
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Decatur
country: United States
state: Illinois
city: Hines
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: North Chicago
country: United States
state: Illinois
city: Anderson
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Lafayette
country: United States
state: Indiana
city: Muncie
country: United States
state: Indiana
city: Clive
country: United States
state: Iowa
city: Des Moines
country: United States
state: Iowa
city: Des Moines
country: United States
state: Iowa
city: Dubuque
country: United States
state: Iowa
city: Iowa City
country: United States
state: Iowa
city: Bowling Green
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Muskegon
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Ocean Springs
country: United States
state: Mississippi
city: Everton
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Butte
country: United States
state: Montana
city: Missoula
country: United States
state: Montana
city: Lebanon
country: United States
state: New Hampshire
city: Cedar Knolls
country: United States
state: New Jersey
city: Neptune
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Trenton
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: New York
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Akron
country: United States
state: Ohio
city: Centerville
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Allentown
country: United States
state: Pennsylvania
city: Doylestown
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Hermitage
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Danville
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Winchester
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
city: Eau Claire
country: United States
state: Wisconsin
city: Marshfield
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Kelowna
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Winnipeg
country: Canada
state: Manitoba
city: Moncton
country: Canada
state: New Brunswick
city: Saint John
country: Canada
state: New Brunswick
city: Halifax
country: Canada
state: Nova Scotia
city: Ajax
country: Canada
state: Ontario
city: Guelph
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Kingston
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Peterborough
country: Canada
state: Ontario
city: Scarborough
country: Canada
state: Ontario
city: Thunder Bay
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Green Field Park
country: Canada
state: Quebec
city: Levis
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Sainte Foy
country: Canada
state: Quebec
city: St-Hyacinthe
country: Canada
state: Quebec
city: St. Charles Borromee
country: Canada
state: Quebec
city: Trois Rivieres
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Johnson S, Louie TJ, Gerding DN, Cornely OA, Chasan-Taber S, Fitts D, Gelone SP, Broom C, Davidson DM; Polymer Alternative for CDI Treatment (PACT) investigators. Vancomycin, metronidazole, or tolevamer for Clostridium difficile infection: results from two multinational, randomized, controlled trials. Clin Infect Dis. 2014 Aug 1;59(3):345-54. doi: 10.1093/cid/ciu313. Epub 2014 May 5.