A study to describe treatment and outcome in patients with diarrhea caused by bacteria Clostridium difficile in Asian Pacific countries
Not Applicable
- Conditions
- Health Condition 1: null- Clostridium difficile Infection
- Registration Number
- CTRI/2014/08/004859
- Lead Sponsor
- Otsuka Pharmaceutical Co Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 627
Inclusion Criteria
Patients must meet the following criteria in order to be enrolled in the study:
•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 who meet the following criteria will not be enrolled in the study:
•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
- Primary Outcome Measures
Name Time Method â?¢To assess the characteristics of patients with CDI in terms of patient demographics, medical <br/ ><br>history, prior and concomitant medications, including antimicrobial agents, clinical laboratory <br/ ><br>data, and disease characteristics <br/ ><br>â?¢ To describe the diagnosis, management and treatment regimen(s) of patients with CDI <br/ ><br>â?¢ To describe clinical outcomes of CDI patients, including recurrence of CDI <br/ ><br>â?¢ To obtain the stool sample from the patients with CDI for further analysis.Timepoint: Throughout the study
- Secondary Outcome Measures
Name Time Method Clinical complications and date of onset/occurrence: <br/ ><br>Dehydration, <br/ ><br>Hypokalemia, <br/ ><br>Toxic megacolon, <br/ ><br>Colonic perforation, <br/ ><br>Peritonitis, <br/ ><br>Fulminant colitis, <br/ ><br>Septic shock, <br/ ><br>Emergency colectomy or other related procedure, <br/ ><br>Other, specify, <br/ ><br>Mortality, <br/ ><br>Date of death, <br/ ><br>Primary cause of deathTimepoint: Throughout the study;Recurrence, <br/ ><br>Date of recurrence, <br/ ><br>Duration of recurrence, <br/ ><br>Severity of recurrent CDI, <br/ ><br>Medication for treatment, <br/ ><br>Final outcome of recurrent caseTimepoint: After 2 months follow up of final outcome by telephone;Status at the end of CDI episode (e.g., complete resolution of CDI)Timepoint: From CDI diagnosis until end of the CDI episode