Antibiotic-Associated Diarrhea, Clostridium Difficile Diarrhea, Pseudomembranous Colitis
Conditions
Keywords
Clostridium difficile-associated diarrhea, C. difficile, CDAD, Clostridium difficile, Clostridium difficile Disease, Clostridium Enterocolitis, Antibiotic-Associated Colitis, Infectious diarrhea
Brief summary
Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition to current standard antibiotic treatment so that 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 7 days.
Interventions
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
Exclusion criteria
* \> 72 hours of treatment with metronidazole, vancomycin, or other antibacterial therapy specifically targeting the current acute episode of CDAD * Patient not considered sufficiently stable clinically to complete the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values | — |
Countries
Canada
Outcome results
None listed