Clostridium Difficile Infection
Conditions
Brief 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.
Interventions
OTHERCDI Pts
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Demographics | At the study at the time of CDI diagnosis enrollment | 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. |
| Status at the End of CDI Episode | From the time of CDI diagnosis to the end of the treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Complication | From the time of CDI diagnosis to recovery or recurrence | 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. |
| Recurrence or Not After 2 Months Follow-up | From the time of CDI diagnosis to 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 |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clostridium Difficile Infection Patient with Clostridium Difficile Infection | 600 |
| Total | 600 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 31 |
| Overall Study | Lost to Follow-up | 73 |
Baseline characteristics
| Characteristic | Clostridium Difficile Infection |
|---|---|
| Age, Categorical <=18 years | 79 Participants |
| Age, Categorical >=65 years | 280 Participants |
| Age, Categorical Between 18 and 65 years | 241 Participants |
| Age, Continuous | 63.0 years |
| Region of Enrollment Australia | 60 participants |
| Region of Enrollment China | 64 participants |
| Region of Enrollment Hong Kong | 36 participants |
| Region of Enrollment India | 2 participants |
| Region of Enrollment Indonesia | 7 participants |
| Region of Enrollment Japan | 48 participants |
| Region of Enrollment Korea, Republic of | 99 participants |
| Region of Enrollment Malaysia | 2 participants |
| Region of Enrollment Philippines | 9 participants |
| Region of Enrollment Singapore | 66 participants |
| Region of Enrollment Taiwan | 99 participants |
| Region of Enrollment Thailand | 44 participants |
| Region of Enrollment Vietnam | 64 participants |
| Sex: Female, Male Female | 272 Participants |
| Sex: Female, Male Male | 328 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: At the study at the time of CDI diagnosis enrollment
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medical History | Patient Demographics | Myocardial infarction | 54 participants |
| Medical History | Patient Demographics | Congestive heart failure | 46 participants |
| Medical History | Patient Demographics | Cerebrovascular disease | 63 participants |
| Medical History | Patient Demographics | Peripheral vascular disease | 29 participants |
| Medical History | Patient Demographics | Chronic pulmonary disease | 57 participants |
| Medical History | Patient Demographics | Connective tissue disease | 72 participants |
| Medical History | Patient Demographics | Peptic ulcer disease | 69 participants |
| Medical History | Patient Demographics | Liver disease | 76 participants |
| Medical History | Patient Demographics | Diabetes mellitus | 154 participants |
| Medical History | Patient Demographics | Renal disease | 143 participants |
| Medical History | Patient Demographics | Solid tumor | 145 participants |
| Medical History | Patient Demographics | Leukaemia | 44 participants |
| Medical History | Patient Demographics | Lymphoma | 39 participants |
| Medical History | Patient Demographics | AIDS | 3 participants |
| Medical History | Patient Demographics | IBD | 68 participants |
| Medical History | Patient Demographics | Nasogastric tube in past 30 days | 107 participants |
| Medical History | Patient Demographics | Abdominal surgery in past 30 days | 36 participants |
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.
Time frame: From the time of CDI diagnosis to the end of the treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medical History | Status at the End of CDI Episode | Lost to follow-up | 7 participants |
| Medical History | Status at the End of CDI Episode | Resolved | 562 participants |
| Medical History | Status at the End of CDI Episode | Death | 31 participants |
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.
Time frame: From the time of CDI diagnosis to recovery or recurrence
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medical History | Clinical Complication | Emergency colectomy performed | 2 participants |
| Medical History | Clinical Complication | Colonoscopy/sigmoidoscopy performed | 2 participants |
| Medical History | Clinical Complication | Colitis or PMC | 83 participants |
| Medical History | Clinical Complication | Toxic megacolon | 1 participants |
| Medical History | Clinical Complication | Hypokalaemia | 23 participants |
| Medical History | Clinical Complication | Hypotension | 1 participants |
| Medical History | Clinical Complication | Dehydration | 17 participants |
| Medical History | Clinical Complication | Septic shock | 9 participants |
| Medical History | Clinical Complication | Peritonitis | 4 participants |
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
Time frame: From the time of CDI diagnosis to 2 months follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medical History | Recurrence or Not After 2 Months Follow-up | Unknown | 220 participants |
| Medical History | Recurrence or Not After 2 Months Follow-up | Recurrence | 48 participants |
| Medical History | Recurrence or Not After 2 Months Follow-up | No recurrence | 332 participants |