The Risk for Clostridium Difficile Colitis During Hospitalization in Asymptomatic Carriers

Completed

• Conditions: Clostridium Difficile; Colitis

• Registration Number: NCT02063282
• Lead Sponsor: Amos Yinnon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-14
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 394

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of colitis	Daily follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Duration until development of colitis	Daily follow-up	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.
Severity of colitis	Daily follow-up	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.

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel