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

NCT01560832 | Completed

• 1 other identifier: 4-2011-0382
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

• To estimate the incidence of laboratory-confirmed hospital-onset CDI cases for hospitalized adult patients

  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).

  every 5 days after consented to enroll the exam

Study Arms (1)

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 Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Age \< 20 years

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (5)

• Gerding DN, Olson MM, Peterson LR, Teasley DG, Gebhard RL, Schwartz ML, Lee JT Jr. Clostridium difficile-associated diarrhea and colitis in adults. A prospective case-controlled epidemiologic study. Arch Intern Med. 1986 Jan;146(1):95-100.

  PMID: 3942469 BACKGROUND

• Anand A, Bashey B, Mir T, Glatt AE. Epidemiology, clinical manifestations, and outcome of Clostridium difficile-associated diarrhea. Am J Gastroenterol. 1994 Apr;89(4):519-23.

  PMID: 8147353 BACKGROUND

• Bartlett JG. Clostridium difficile: history of its role as an enteric pathogen and the current state of knowledge about the organism. Clin Infect Dis. 1994 May;18 Suppl 4:S265-72. doi: 10.1093/clinids/18.supplement_4.s265.

  PMID: 8086574 BACKGROUND

• McDonald LC, Coignard B, Dubberke E, Song X, Horan T, Kutty PK; Ad Hoc Clostridium difficile Surveillance Working Group. Recommendations for surveillance of Clostridium difficile-associated disease. Infect Control Hosp Epidemiol. 2007 Feb;28(2):140-5. doi: 10.1086/511798. Epub 2007 Jan 25.

  PMID: 17265394 BACKGROUND

• Zar FA, Bakkanagari SR, Moorthi KM, Davis MB. A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile-associated diarrhea, stratified by disease severity. Clin Infect Dis. 2007 Aug 1;45(3):302-7. doi: 10.1086/519265. Epub 2007 Jun 19.

  PMID: 17599306 BACKGROUND

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 22, 2012
• Study Start: December 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

KR (1)