Prospective Observational Study of Clostridium Difficile Infection in Asian Pacific Countries

Study Overview
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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.

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

Conditions
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Clostridium Difficile Infection

Intervention / Treatment
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* Other: CDI Pts


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CDI<br> | Other: CDI Pts<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Demographics | 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. | At the study at the time of CDI diagnosis enrollment | 
| Status at the End of CDI Episode | 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. | From the time of CDI diagnosis to the end of the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Complication | 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. | From the time of CDI diagnosis to recovery or recurrence | 
| Recurrence or Not After 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 | From the time of CDI diagnosis to 2 months follow-up |