Are you at risk for C.diff? • Do you have an upcoming SURGERY, requiring you to be hospitalized for several days? • Have you been HOSPITALIZED TWICE in the last year and received antibiotics? • Are you 50 years of age or older?

  • STATUS
    Recruiting
  • sponsor
    Sanofi-Pasteur
Updated on 23 November 2020

Summary

Are you at risk for C.diff? • Do you have an upcoming SURGERY, requiring you to be hospitalized for several days? • Have you been HOSPITALIZED TWICE in the last year and received antibiotics? • Are you 50 years of age or older?

Description

Individuals most at-risk for C. diff have a generally weakened condition, have received antibiotics, and are likely to have been hospitalized or residing in Long Term Care Facilities. Clostridium difficile (C-diff) is a potentially deadly, spore-forming bacterium emerging as the leading cause of life-threatening, healthcare-associated infections worldwide.

C.diff toxins cause gastrointestinal disease that can lead to death. Symptoms range from mild diarrhea to life-threatening colitis and often include dehydration, abdominal pain and spasms.

350,000 American people are hospitalized every year due to this disease, 77% of cases being in people above 50 years old. In hospital wards, C.diff contamination has been found on 49% of sites in rooms occupied by previous patients with C.diff even after cleaning measures.

Other Details:

You may be eligible to help us develop a vaccine to protect at risk individuals like yourself from a serious healthcare associated infection; Clostridium difficile.

Details
Condition Clostridium Difficile-Associated Diarrhea
Clinical Study IdentifierTX141065
SponsorSanofi-Pasteur
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and Female aged >50 years
Able to attend all scheduled visits and to comply with all trial procedures
Must Fulfill at Least 1 of the Following
Has had at least 2 hospital stays, each lasting at least >24 hours, in the 12 months before enrollment
Has received systemic (not topical) antibiotics in the 12 months before enrollment
OR
Is anticipated to have an in-patient hospitalization for a planned surgical procedure within 60 days of enrollment. The impending hospital stay is planned to be >72 hours for a surgery involving 1 of the following
Kidney/Bladder/Urinary system
Musculoskeletal system
Respiratory system
Circulatory system
Central Nervous system
If an individual is either an in-patient in the hospital or had a previous hospitalization, the enrollment date must be at least 30 days from hospital discharge
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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