Prospective Observational Study of Clostridium Difficile Infection in Asian Pacific Countries

NCT02223715 | Completed Results

• 1 other identifier: 341-12-003
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Clinical Complication

  From the time of CDI diagnosis to recovery or recurrence

• Recurrence or Not After 2 Months Follow-up

  From the time of CDI diagnosis to 2 months follow-up

Study Arms (1)

CDI

Other: CDI Pts

Interventions

CDI Pts OTHER

CDI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a confirmed diagnosis of CDI(C. difficile infection) who willing to provide informed consent and/or informed assent or data release, according to local regulation.

You may qualify if:

• 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

You may not qualify if:

• Patients with diarrheal symptoms caused by bacteria other than C. difficile, such as Salmonella, Campylobacter, Vibrio, Shigella, and Escherichia coli.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Kanto Region, Japan

Location

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Study Director, Yoshitaka Kotobuki, Mr
• Organization: Otsuka Pharmaceutical Co., LTD.

+81-3-6361-7366

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: August 22, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: October 17, 2016
• Results First Posted: October 17, 2016

Record last verified: 2016-08

Locations

JP (1)