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NCT02063282 Clinical Trial

The Risk for Clostridium Difficile Colitis During Hospitalization in Asymptomatic Carriers

Clostridium Difficile Clinical Trial

Official title:
The Risk for Clostridium Difficile Colitis During Hospitalization in Asymptomatic Carriers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02063282
Other study ID # ShaareZMC
Secondary ID
Status Completed
Phase N/A
First received February 11, 2014
Last updated April 20, 2016
Start date February 2014
Est. completion date December 2014

Study information
Verified date April 2016
Source Shaare Zedek Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 394
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- History of hospitalization in recent year, residence of a nursing home or institutions

- Expected more than 48 hours hospitalization

Exclusion Criteria:

- Colitis/ diarrhea

- Rectal swab performed =48 hrs post arrival to hospital.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Shaare Zedek Medical Center Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Amos Yinnon

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Duration until 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 No
Secondary Severity 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 No
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