A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea
A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole, in Patients With C.Difficile - Associated Diarrhea
1 other identifier
interventional
520
3 countries
140
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2005
140 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 25, 2005
CompletedFirst Posted
Study publicly available on registry
March 28, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedMarch 5, 2015
March 1, 2015
March 25, 2005
March 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Resolution of diarrhea
Secondary Outcomes (5)
Time to resolution of diarrhea
Recurrence rate
Number of stools
Average stool consistency
Treatment success
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (140)
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Phoenix, Arizona, 85006, United States
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Phoenix, Arizona, 85012, United States
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Rogers, Arkansas, 72756, United States
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Burbank, California, 91505, United States
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Los Angeles, California, 90073, United States
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Los Angeles, California, 90089, United States
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Los Angeles, California, 90095, United States
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Modesto, California, 95350, United States
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Newport Beach, California, 92663, United States
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Sacramento, California, 95817, United States
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San Diego, California, 92103, United States
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Denver, Colorado, 80204, United States
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Denver, Colorado, 80210, United States
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Denver, Colorado, 80218-1191, United States
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Denver, Colorado, 80262, United States
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Newark, Delaware, 19718, United States
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Bay Pines, Florida, 33744, United States
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Brandon, Florida, 33511, United States
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Brooksville, Florida, 34613, United States
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Jacksonville, Florida, 32207, United States
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Tampa, Florida, 33607, United States
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Zephyrhills, Florida, 33542, United States
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Atlanta, Georgia, 30309, United States
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Fort Eisenhower, Georgia, 30905, United States
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Savannah, Georgia, 31405, United States
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Honolulu, Hawaii, 96813, United States
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Chicago, Illinois, 60634, United States
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Decatur, Illinois, 62526, United States
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Hines, Illinois, 60141, United States
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Maywood, Illinois, 60153, United States
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North Chicago, Illinois, 60064, United States
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Anderson, Indiana, 46011, United States
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Indianapolis, Indiana, 46202, United States
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Lafayette, Indiana, 47904, United States
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Muncie, Indiana, 47303, United States
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Clive, Iowa, 50325, United States
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Des Moines, Iowa, 50302, United States
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Des Moines, Iowa, 50309, United States
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Dubuque, Iowa, 52002, United States
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Iowa City, Iowa, 52242, United States
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Bowling Green, Kentucky, 42101, United States
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Louisville, Kentucky, 40202, United States
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Louisville, Kentucky, 40206-1499, United States
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New Orleans, Louisiana, 70115, United States
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New Orleans, Louisiana, 70121, United States
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Baltimore, Maryland, 21201, United States
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Hagerstown, Maryland, 21740, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02115, United States
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Worcester, Massachusetts, 01608-1320, United States
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Worcester, Massachusetts, 01655, United States
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Detroit, Michigan, 48201, United States
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Detroit, Michigan, 48202, United States
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Muskegon, Michigan, 49444, United States
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Rochester, Minnesota, 55905, United States
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Ocean Springs, Mississippi, 39564, United States
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Everton, Missouri, 65646, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63110, United States
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Butte, Montana, 59701, United States
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Missoula, Montana, 59802, United States
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Lebanon, New Hampshire, 03756, United States
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Cedar Knolls, New Jersey, 07927, United States
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Neptune City, New Jersey, 07753, United States
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Newark, New Jersey, 07103, United States
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Trenton, New Jersey, 08629, United States
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Albany, New York, 12208, United States
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New Hyde Park, New York, 11040, United States
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New York, New York, 10016, United States
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Syracuse, New York, 13210, United States
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Asheville, North Carolina, 28801, United States
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Greenville, North Carolina, 27834, United States
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Raleigh, North Carolina, 27612, United States
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Fargo, North Dakota, 58122, United States
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Akron, Ohio, 44304, United States
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Centerville, Ohio, 45459, United States
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Toledo, Ohio, 43608, United States
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Allentown, Pennsylvania, 18102, United States
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Doylestown, Pennsylvania, 18901, United States
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Lancaster, Pennsylvania, 17602, United States
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Philadelphia, Pennsylvania, 19140, United States
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Philadelphia, Pennsylvania, 19141, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Pittsburgh, Pennsylvania, 15261, United States
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Charleston, South Carolina, 29401, United States
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Greenville, South Carolina, 29605, United States
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Rapid City, South Dakota, 57701, United States
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Hermitage, Tennessee, 37076, United States
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Houston, Texas, 77030, United States
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Tyler, Texas, 75702, United States
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Burlington, Vermont, 05403, United States
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Danville, Virginia, 24541, United States
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Richmond, Virginia, 23249, United States
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Richmond, Virginia, 23298, United States
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Winchester, Virginia, 22601, United States
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Tacoma, Washington, 98431, United States
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Eau Claire, Wisconsin, 54710, United States
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Marshfield, Wisconsin, 54449, United States
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Milwaukee, Wisconsin, 53226, United States
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Calgary, Alberta, T2N 2T9, Canada
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Edmonton, Alberta, T5H 3V9, Canada
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Kelowna, British Columbia, V1V 1Y5, Canada
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Kelowna, British Columbia, V1Y 1T2 & V1Y3G8, Canada
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Vancouver, British Columbia, V5Z 3J5, Canada
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Victoria, British Columbia, V8R 1J8, Canada
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Winnipeg, Manitoba, R3A 1R9, Canada
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Winnipeg, Manitoba, R3C 0N2, Canada
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Moncton, New Brunswick, E1C 6Z8, Canada
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Saint John, New Brunswick, E2K 4L2, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Guelph, Ontario, N1E 4J4, Canada
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Hamilton, Ontario, L8N 4A6, Canada
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Kingston, Ontario, K7L 3N6, Canada
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London, Ontario, N6A 4G5, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Peterborough, Ontario, K9J 7B3, Canada
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Scarborough Village, Ontario, M1E 4B9, Canada
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Thunder Bay, Ontario, P7B 6V1, Canada
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Toronto, Ontario, M2K 1E1, Canada
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Toronto, Ontario, M3N 2V6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Toronto, Ontario, M5G 2M9 & M5G 1X5, Canada
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Windsor, Ontario, N8X 3V6, Canada
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Windsor, Ontario, N9A 1E1, Canada
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Chicoutimi, Quebec, G7H 5H6, Canada
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Green Field Park, Quebec, J4V 2H1, Canada
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Lévis, Quebec, G6V 3Z1, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Québec, Quebec, G1L 3L5, Canada
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Québec, Quebec, G1R 2J6, Canada
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Saint-Charles-Borromée, Quebec, J6E 2C3, Canada
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Saint-Hyacinthe, Quebec, J2S 4Y8, Canada
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Sainte-Foy, Quebec, G1V 4G2, Canada
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Trois-Rivières, Quebec, G9A 1Y1, Canada
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Saskatoon, Saskatchewan, S7K 1J5, Canada
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San Juan, 00935, Puerto Rico
Related Publications (1)
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.
PMID: 24799326DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 25, 2005
First Posted
March 28, 2005
Study Start
March 1, 2005
Study Completion
February 1, 2007
Last Updated
March 5, 2015
Record last verified: 2015-03