Health Condition 1: null- Clostridium difficile Infection
Conditions
Interventions
None listed
Sponsors
Otsuka Pharmaceutical Co Ltd
PAREXEL International Clinical Research Private Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ To assess the characteristics of patients with CDI in terms of patient demographics, medical history, prior and concomitant medications, including antimicrobial agents, clinical laboratory data, and disease characteristics â?¢ To describe the diagnosis, management and treatment regimen(s) of patients with CDI â?¢ To describe clinical outcomes of CDI patients, including recurrence of CDI â?¢ To obtain the stool sample from the patients with CDI for further analysis.Timepoint: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical complications and date of onset/occurrence: Dehydration, Hypokalemia, Toxic megacolon, Colonic perforation, Peritonitis, Fulminant colitis, Septic shock, Emergency colectomy or other related procedure, Other, specify, Mortality, Date of death, Primary cause of deathTimepoint: Throughout the study;Recurrence, Date of recurrence, Duration of recurrence, Severity of recurrent CDI, Medication for treatment, 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 | — |
Countries
Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Philippines, Republic of Korea, Singapore, Taiwan, Thailand, Viet Nam
Contacts
Public ContactDr Annappa Kamath
PAREXEL International Clinical Research Private Limited
Outcome results
None listed