Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection
Completed · Phase 2 · Has a placebo group
Conditions studied: Diarrhea, Clostridium Difficile Infection
In brief
Primary objective: To compare the event rate of CDI in groups assigned to ACAM-CDIFF™ vaccine versus placebo in the 9 week period after the third dose of the study vaccine in subjects with first episode of CDI receiving antibiotics standard of care. Secondary objective: To evaluate the safety of all dose groups of ACAM-CDIFF™ vaccine versus placebo in subjects with first episode of CDI receiving antibiotics standard of care.
Key facts
- Study ID
- NCT00772343
- Run by
- Sanofi Pasteur, a Sanofi Company
- People needed
- 116
- Starts
- 2009-02-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2013-09-17
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult subjects, 18 - 85 years old, who understand the risks and benefits of participation and have provided written informed consent for the study.
- Subjects who are experiencing a first event of CDI diagnosed within the last 10 days.
- Subjects who are medically stable.
- Subjects who are willing and able to comply with the study procedures and visit schedules outlined.
You may not qualify if…
- Subjects who are currently on treatment for a recurrence of CDI.
- Subjects who are currently or have recently been treated with immunoglobulin therapy.
- Pregnant or breast feeding females.
- Concurrent, acutely life-threatening diseases.
Where it is running
- Study site — Tampa, Florida, United States
- Study site — Marietta, Georgia, United States
- Study site — Worcester, Massachusetts, United States
- Study site — Butte, Montana, United States
- Study site — Rapid City, South Dakota, United States
- Birmingham Heartlands Hospital — Birmingham, United Kingdom
- Blackpool Victoria Hospital — Blackpool, United Kingdom
- Bradford Royal Infirmary — Bradford, United Kingdom
- Royal Sussex County Hospital — Brighton, United Kingdom
- Southmead Hospital — Bristol, United Kingdom
- Frenchay Hospital — Bristol, United Kingdom
- St Helier Hospital — Carshalton, United Kingdom
- Cheltenham Royal Hosptial — Cheltenham, United Kingdom
- St. Richard's Hospital — Chichester, United Kingdom
- New University Hospital (Walsgrave site) — Coventry, United Kingdom
- Ninewells Hospital — Dundee, United Kingdom
- West Park Hospital — Epsom, United Kingdom
- Gloucestersh Royal Hospital — Gloucester, United Kingdom
- Leeds General Infirmary — Leeds, United Kingdom
- Leicester Royal Infirmary — Leicester, United Kingdom
- Whittington Hospital — London, United Kingdom
- North Manchester General Hospital — Manchester, United Kingdom
- Royal Oldham Hospital — Manchester, United Kingdom
- St Mary's Hospital — Portsmouth, United Kingdom
- Queen Alexandra Hospital — Portsmouth, United Kingdom
Full record on ClinicalTrials.gov
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