Status:
COMPLETED
Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Diarrhea
Clostridium Difficile Infection
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
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 episo...
Detailed Description
This study is designed primarily to obtain information on the preliminary efficacy, safety and immunogenicity of ACAM-CDIFF™ vaccine, as compared to placebo in subjects who are experiencing their firs...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00772343
Start Date
February 1 2009
End Date
June 1 2012
Last Update
September 17 2013
Active Locations (31)
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1
Tampa, Florida, United States, 33614
2
Marietta, Georgia, United States, 33360
3
Worcester, Massachusetts, United States, 01608
4
Butte, Montana, United States, 59701