The Risk for Clostridium Difficile Colitis During Hospitalization in Asymptomatic Carriers

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02063282

Enrollment

394

Registered

2014-02-14

Start date

2014-02-28

Completion date

2014-12-31

Last updated

2016-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile, Colitis

Keywords

Asymptomatic, Carriage, Colonization, Clostridium difficile, Colitis, Rectal swab

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Israel

Outcome results