Prospective Observational Study of Clostridium Difficile Infection in Asian Pacific Countries

Otsuka

Status: Completed

Conditions: Clostridium Difficile Infection

Treatments: Other: CDI Pts

Study type: Observational

Funder types: Industry

Identifiers

NCT02223715

341-12-003

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 1 patient group

CDI

Treatment:

Other: CDI Pts