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NCT02223715 Clinical Trial

A Prospective Study to Characterize the Management and Outcome of Clostridium Difficile Infection (CDI) in Asian Pacific Countries

Clostridium Difficile Infection Clinical Trial

Official title:
A Prospective Study to Characterize the Management and Outcome of Clostridium Difficile Infection in Asian Pacific Countries

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02223715
Other study ID # 341-12-003
Secondary ID
Status Completed
Phase N/A
First received April 22, 2014
Last updated May 25, 2016
Start date March 2014
Est. completion date January 2015

Study information
Verified date May 2016
Source Otsuka Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Observational

Clinical Trial Summary

The aim of this study is to conduct an Asia-Pacific, multi-center, prospective observational study to characterize patients with CDI as well as to understand treatment and management of the disease.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with a confirmed diagnosis of CDI, as documented by diarrheal symptoms and positive stool test result for CDT or toxigenic C. difficile, or colonoscopic findings of PMC

- Patients and/or legal guardian willing to provide informed consent and/or informed assent or data release, according to local regulations

Exclusion Criteria:

- Patients with diarrheal symptoms caused by bacteria other than C. difficile, such as Salmonella, Campylobacter, Vibrio, Shigella, and Escherichia coli.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• CDI Pts

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient demographics At the study enrollment No
Primary Status at the end of CDI episode At the end of the treatment No
Secondary Clinical complication From CDI diagnosis to recovery or recurrence No
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