N/A
N=600
Prospective Observational Study of Clostridium Difficile Infection in Asian Pacific Countries
Clostridium Difficile Infection
Bottom Line
View on ClinicalTrials.gov: NCT02223715 ↗Enrolled (actual)
600
Serious AEs
—
Results posted
Oct 2016
Primary outcome: Primary: Patient Demographics — 54; 46; 63; 29 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- CDI Pts (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Demographics |
54; 46; 63; 29; 57; 72 | — |
| PRIMARY Status at the End of CDI Episode |
7; 562; 31 | — |
| SECONDARY Clinical Complication |
2; 2; 83; 1; 23; 1 | — |
| SECONDARY Recurrence or Not After 2 Months Follow-up |
48; 332; 220 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02223715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.