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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDI |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDI Pts | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Complication | This study was non-interventional observational study. There were no restriction on the CDI treatment and we did not define to collect AE data. We just defined to collect the data for complications with CDI treatments indicating below. The complications to be checked were defined in the protocol. The information of other complications and AEs were not collected. | From the time of CDI diagnosis to recovery or recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanto Region | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clostridium Difficile Infection | To characterize the ｍanagement and outcome of Clostridium Difficile Infection in asian pacific countries |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Clostridium Difficile Infection | Patient with Clostridium Difficile Infection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | participants | At the study at the time of CDI diagnosis enrollment |
|
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Adverse Events were not pre-specified to be collected for this observational study. However, complications associated with CDI treatment were collected and are reported as an Outcome Measure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clostridium Difficile Infection | Patient with Clostridium Difficile Infection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director, Yoshitaka Kotobuki, Mr | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Recurrence or Not After 2 Months Follow-up | 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. Unknown includes patient lost, data missing | From the time of CDI diagnosis to 2 months follow-up |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Primary | 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. | Posted | Number | participants | From the time of CDI diagnosis to the end of the treatment |
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|
| Secondary | Clinical Complication | This study was non-interventional observational study. There were no restriction on the CDI treatment and we did not define to collect AE data. We just defined to collect the data for complications with CDI treatments indicating below. The complications to be checked were defined in the protocol. The information of other complications and AEs were not collected. | Posted | Number | participants | From the time of CDI diagnosis to recovery or recurrence |
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| Secondary | Recurrence or Not After 2 Months Follow-up | 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. Unknown includes patient lost, data missing | Posted | Number | participants | From the time of CDI diagnosis to 2 months follow-up |
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| Title | Measurements |
|---|---|
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| Title |
|---|
| Measurements |
|---|
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| Toxic megacolon |
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| Hypokalaemia |
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| Hypotension |
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| Dehydration |
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| Septic shock |
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| Peritonitis |
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