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
13 countries
120
Brief Summary
Approximately 520 patients will be entered into this study taking place throughout Australia and Europe. 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. The 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 Apr 2005
120 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedMarch 19, 2014
March 1, 2014
September 13, 2005
March 17, 2014
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 and above
- 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 6 week study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (138)
Unknown Facility
Adelaide, 5000, Australia
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Bedford Park, 5042, Australia
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Cairns, 4870, Australia
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Concord, 2139, Australia
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Darlinghurst, 2010, Australia
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Five Dock, 2046, Australia
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Footscray, 3011, Australia
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Herston, 4032, Australia
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Hobart, 7000, Australia
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Kogarah, 2217, Australia
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Nambour, 4560, Australia
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Nedlands, 6009, Australia
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Parkville, 3050, Australia
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Perth, 6000, Australia
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Randwick, 2031, Australia
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South Brisbane, 4101, Australia
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Southport, 4215, Australia
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Woolloongabba, 4102, Australia
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Innsbruck, 6020, Austria
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Linz, 4010, Austria
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Linz, 4020, Austria
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Oberndorf, 5110, Austria
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Salzburg, 5020, Austria
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Aalst, 9300, Belgium
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Braine-l'Alleud, 1420, Belgium
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Brussels, 1000, Belgium
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Brussels, 1070, Belgium
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Brussels, 1200, Belgium
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Ghent, B-9000, Belgium
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Hasselt, 3500, Belgium
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Leuven, 3000, Belgium
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Yvoir, B-5330, Belgium
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Brno, 62500, Czechia
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Hradec Králové, 50005, Czechia
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Mělník, 276 01, Czechia
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Ostrava, 708 52, Czechia
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Prague, 128 20, Czechia
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Prague, 180 81, Czechia
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Copenhagen, DK-2200, Denmark
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Copenhagen, DK-2400, Denmark
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Herlev, DK-2730, Denmark
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Hvidovre, DK-2650, Denmark
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Amiens, 80054, France
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Annecy, 74000, France
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Clichy, 92110, France
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Créteil, 94010, France
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Dijon, 21000, France
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Garches, 92380, France
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Nice, 06200, France
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Paris, 75010, France
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Paris, 75018, France
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Paris, 75020, France
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Paris, 75679, France
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Saint-Etienne, 42055, France
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Tourcoing, 59200, France
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Vandœuvre-lès-Nancy, 54511, France
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Augsburg, 86156, Germany
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Berlin, 12200, Germany
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Cologne, 50937, Germany
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Düsseldorf, 40472, Germany
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Frankfurt, 60487, Germany
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Frankfurt, 60590, Germany
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Greifswald, 17491, Germany
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Hanover, 30625, Germany
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Hofheim, 65719, Germany
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Leipzig, 4157, Germany
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Lübeck, 23538, Germany
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Regensburg, 93053, Germany
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Wilhelmshaven, 26384, Germany
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Castlebar, Ireland
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Cork, Ireland
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Dublin, Ireland
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Bergen, N-5009, Norway
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Bergen, N-5021, Norway
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Bodø, N-8005, Norway
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Oslo, N-0407, Norway
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Stavanger, N-4068, Norway
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Tromsø, 9038, Norway
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Trondheim, 7006, Norway
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Tønsberg, 3103, Norway
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Carnaxide, 2790-134, Portugal
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Coimbra, 3000-075, Portugal
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Matosinhos Municipality, 4450, Portugal
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Porto, 4099-001, Portugal
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Alcalá de Henares, 28805, Spain
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Badalona, 8911, Spain
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Badalona, 8915, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, 8025, Spain
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Córdoba, 14004, Spain
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Donostia / San Sebastian, 20014, Spain
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El Palmar-Murcia, 30120, Spain
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Guadalajara, 19002, Spain
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Leganés, 28911, Spain
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Lleida, 25198, Spain
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Madrid, 28007, Spain
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Madrid, 28035, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Santander, 39008, Spain
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Seville, 41013, Spain
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Seville, 41014, Spain
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Seville, 41071, Spain
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Terrassa, 8221, Spain
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Gothenburg, SE-416 85, Sweden
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Jönköping, SE-551 85, Sweden
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Kalmar, SE-391 85, Sweden
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Karlskrona, SE-371 85, Sweden
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Kristianstad, SE-291 85, Sweden
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Lund, SE-221 85, Sweden
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Malmo, SE-205 85, Sweden
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Örebro, SE-701 85, Sweden
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Skövde, SE-541 85, Sweden
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Baden, 5404, Switzerland
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Basel, 4031, Switzerland
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Bellinzona, 6500, Switzerland
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Geneva, 1211, Switzerland
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Lugano, 6903, Switzerland
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Abergavenny, NP7 7EG, United Kingdom
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Birmingham, B15 2TT, United Kingdom
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Bristol, BS16 1LE, United Kingdom
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Bury, BL9 7TD, United Kingdom
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Cardiff, CF14 4XW, United Kingdom
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Cardiff, CF64 2XX, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Gwent, NP20 2UB, United Kingdom
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Ipswich, IP4 5PD, United Kingdom
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Keighley, BD20 6TD, United Kingdom
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Leeds, LS1 3EX, United Kingdom
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Liverpool, L7 8XP, United Kingdom
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London, SE13 6LH, United Kingdom
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London, W1M 3TT, United Kingdom
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Salford, M6 8HD, United Kingdom
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Sheffield, S10 2JF, United Kingdom
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Stockport, SK2 7JE, United Kingdom
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Sunderland, SR4 7TP, United Kingdom
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Winchester, SO22 5DG, United Kingdom
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
September 13, 2005
First Posted
September 20, 2005
Study Start
April 1, 2005
Study Completion
August 1, 2007
Last Updated
March 19, 2014
Record last verified: 2014-03