Prospective Observational Study of Clostridium Difficile Infection in Asian Pacific Countries

NCT ID: NCT02223715

Last Updated: 2016-10-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Clostridium Difficile Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CDI

CDI Pts

Intervention Type OTHER

Interventions

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CDI Pts

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kanto Region, , Japan

Site Status

Countries

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Japan

Other Identifiers

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341-12-003

Identifier Type: -

Identifier Source: org_study_id

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