Clostridium Difficile Infection Clinical Trial
Official title:
A Prospective Study to Characterize the Management and Outcome of Clostridium Difficile Infection in Asian Pacific Countries
Verified date | May 2016 |
Source | Otsuka Pharmaceutical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Observational |
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.
Status | Completed |
Enrollment | 600 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Otsuka Pharmaceutical Co., Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient demographics | At the study enrollment | No | |
Primary | Status at the end of CDI episode | At the end of the treatment | No | |
Secondary | Clinical complication | From CDI diagnosis to recovery or recurrence | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02214771 -
Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients
|
N/A | |
Withdrawn |
NCT01552668 -
Fidaxomicin to Prevent Clostridium Difficile Colonization
|
Phase 4 | |
Recruiting |
NCT03325855 -
Fecal Microbiota Transplant National Registry
|
||
Not yet recruiting |
NCT03586206 -
Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
|
||
Suspended |
NCT03350711 -
A Screening and Recruitment Study in Adults Expressing Interest in the Emory Microbiota Enrichment Program
|
||
Withdrawn |
NCT03643887 -
Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients
|
Phase 2 | |
Terminated |
NCT04000555 -
Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)
|
Phase 4 | |
Terminated |
NCT03065374 -
Treatment for Clostridium-difficile Infection With IMM529
|
Phase 1/Phase 2 | |
Completed |
NCT03710694 -
Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI)
|
N/A | |
Completed |
NCT02865616 -
MET-2 Clinical Study for Recurrent Clostridium Difficile Infection (CDI)
|
Phase 1 | |
Recruiting |
NCT04940468 -
High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology
|
N/A | |
Completed |
NCT02589847 -
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
|
Phase 2 | |
Not yet recruiting |
NCT01942447 -
Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis
|
N/A | |
Active, not recruiting |
NCT02086916 -
Novel Biomarkers to Predict Outcome in Clostridium Difficile Infection
|
N/A | |
Completed |
NCT01230957 -
Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults
|
Phase 2 | |
Completed |
NCT01241552 -
A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)
|
Phase 3 | |
Not yet recruiting |
NCT04567134 -
Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
|
||
Completed |
NCT04075422 -
Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.
|
||
Recruiting |
NCT03712722 -
Fecal Microbiota Transplantation (FMT) for Clostridium Difficile
|
||
Recruiting |
NCT05192148 -
Seroprevalence of Antibodies to Surface Antigens and Toxins of Clostridioides Difficile
|
N/A |