Prospective Observational Study of Clostridium Difficile Infection in Asian Pacific Countries

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.

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Key information

Conditions

Clostridium Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Kanto Region, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CDI Pts

Other

Primary outcomes

Patient Demographics

Time frame: 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.
Status at the End of CDI Episode

Time frame: 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.

Secondary outcomes

Clinical Complication

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Aug 22, 2014
Registry last updated: Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed