Descriptive Epidemiology of Clostridium Difficile Infection in Hospitalized Adult Patients in the Asia Pacific Region

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01560832
First received: March 2, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

Clostridium difficile is an important pathogen, causing disease that ranges from mild self-limited diarrhea to life-threatening pseudomembranous colitis. It is estimated that C. difficile is responsible for 10% to 25% of all cases of antibiotic-associated diarrhea and for almost all cases of pseudomembranous colitis. C. difficile disease is mediated by two large toxins, A and B. The toxins damage intestinal epithelial cells and cause the clinical illness. Primary risk factors for C. difficile clinically apparent infection include antimicrobial therapy, hospitalization, residence in a long-term care facility, older age (≥ 65 years), and increased length of hospital stay. The incidence of CDI both in the hospital and the community is important in the understanding and characterization of the disease and its prevention. This observational, epidemiological study will advance the investigators understanding of CDI risk factors in several hospitals and possibly the community in the Asia Pacific region.


Condition
Clostridium Difficile Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • To estimate the incidence of laboratory-confirmed hospital-onset CDI cases for hospitalized adult patients [ Time Frame: every 5 days after consented to enroll the exam ] [ Designated as safety issue: No ]

    A laboratory-confirmed CDI case is defined as a patient who has experienced the passage of 3 or more unformed or loose stools [diarrhea] conforming to the shape of a container within a 24-hour period and has a positive laboratory test result confirmed by PCR. A hospital onset case is defined as a patient with diarrhea more than 48 hours after admission to a hospital.

    The study period is the study duration, which is defined as the first date of surveillance at each hospital until the sample collection date of the last CDI positive patient (N=100).



Enrollment: 188
Study Start Date: December 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Laboratory (PCR)-confirmed C.difficile infection
patient who has experienced the passage of 3 or more unformed or loose stools [diarrhea] conforming to the shape of a container within a 24-hour period and has a positive laboratory test result confirmed by PCR.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patient who has experienced the passage of 3 or more unformed or loose stools [diarrhea] conforming to the shape of a container within a 24-hour period and has a positive laboratory test result confirmed by PCR.

Criteria

Inclusion Criteria:

  • Adult patients, aged ≥ 20 years at the time of hospitalization in specified wards
  • PCR-diagnosed CDI while at the hospital
  • Informed consent has been obtained from patients as required by local requirements

Exclusion Criteria:

  • Age < 20 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560832

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Publications:
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01560832     History of Changes
Other Study ID Numbers: 4-2011-0382
Study First Received: March 2, 2012
Last Updated: March 4, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014