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OpenTrials
Completed

NCT Number: NCT02063282

The Risk for Clostridium Difficile Colitis During Hospitalization in Asymptomatic Carriers

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shaare Zedek Medical Center

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Development of colitis

    Time frame: 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 outcomes

  1. Duration until development of colitis

    Time frame: 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.

  2. Severity of colitis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Amos Yinnon

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 14, 2014
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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