The Risk for Clostridium Difficile Colitis During Hospitalization in Asymptomatic Carriers
1 other identifier
observational
394
1 country
1
Brief Summary
The investigators hypothesize that development of symptoms characteristic of Clostridium difficile infection will be 2-3 times higher in asymptomatic carriers, compared to that of non carriers and expect to find risk factors for development of symptomatic clostridium difficile.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2014
Shorter than P25 for all trials
1 active site
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
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 11, 2014
CompletedFirst Posted
Study publicly available on registry
February 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedApril 21, 2016
April 1, 2016
10 months
February 11, 2014
April 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Development of colitis
participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Patients' file will be reviewed and the next signs and symptoms will be recorded: abdominal pain, diarrhea, fever and leukocytosis.
Daily follow-up
Secondary Outcomes (2)
Duration until development of colitis
Daily follow-up
Severity of colitis
Daily follow-up
Study Arms (2)
Clostridium difficile carriers
Clostridium difficile non carriers
Eligibility Criteria
Newly admitted patients in the Emergency Department and Internal wards, .
You may qualify if:
- History of hospitalization in recent year, residence of a nursing home or institutions
- Expected more than 48 hours hospitalization
You may not qualify if:
- Colitis/ diarrhea
- Rectal swab performed ≥48 hrs post arrival to hospital.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amos Yinnonlead
Study Sites (1)
Shaare Zedek Medical Center
Jerusalem, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 11, 2014
First Posted
February 14, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
April 21, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share