Prospective Observational Study of Clostridium Difficile Infection in Asian Pacific Countries

Completed

• Conditions: Clostridium Difficile Infection
• Interventions: Other: CDI Pts

• Registration Number: NCT02223715
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-08-20
• Study First Posted: 2014-08-22
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2016-06-28
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-23
• Last Update Submitted: 2016-08-23
• Results First Posted: 2016-10-17
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CDI	CDI Pts	-

Primary Outcome Measures

Name	Time	Method
Status at the End of CDI Episode	From the time of CDI diagnosis to the end of the treatment	The patients were observed from the diagnosis to the end of the treatment and got a telephone follow up call after two month from the end of treatment. The categories of the status indicating below are at the end of the treatment, not at the follow up call. Lost to follow-up means the patient number who were lost during the treatment course.
Patient Demographics	At the study at the time of CDI diagnosis enrollment	Medical history is information which was collected at the CDI diagnosis in this study. The items of the Medical history are indicated below. Concomitant diseases at the CDI diagnosis were included in the Medical history.

Secondary Outcome Measures

Name	Time	Method
Clinical Complication	From the time of CDI diagnosis to recovery or recurrence	This study was non-interventional observational study. There were no restriction on the CDI treatment and we did not define to collect AE data. We just defined to collect the data for complications with CDI treatments indicating below. The complications to be checked were defined in the protocol. The information of other complications and AEs were not collected.
Recurrence or Not After 2 Months Follow-up	From the time of CDI diagnosis to 2 months follow-up	The patients were observed from the diagnosis to the end of the treatment and got a telephone follow up call after two month from the end of treatment.; Unknown includes patient lost, data missing