An observational study in Clostridium Difficile Infection, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2016-10-17.
Sponsored by Otsuka Pharmaceutical Co., Ltd. (part of Otsuka Holdings Co., Ltd.) · 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.
313 studies on the registry are indexed under Clostridium Infections; 51 are open to participants now.
This study's enrollment of 600 is above the median of 227 across 59 observational studies indexed under Clostridium Infections.
Browse Clostridium Infections studies →Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 143 studies on the registry; 11 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: CDI Pts
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
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
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
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
| Milestone | Clostridium Difficile Infection |
|---|---|
| Started | 600 |
| Completed | 496 |
| Not completed | 104 |
| Withdrew: Death | 31 |
| Withdrew: Lost to follow-up | 73 |
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.
| participants | Medical History |
|---|---|
| Myocardial infarction | 54 |
| Congestive heart failure | 46 |
| Cerebrovascular disease | 63 |
| Peripheral vascular disease | 29 |
| Chronic pulmonary disease | 57 |
| Connective tissue disease | 72 |
| Peptic ulcer disease | 69 |
| Liver disease | 76 |
| Diabetes mellitus | 154 |
| Renal disease | 143 |
| Solid tumor | 145 |
| Leukaemia | 44 |
| Lymphoma | 39 |
| AIDS | 3 |
| IBD | 68 |
| Nasogastric tube in past 30 days | 107 |
| Abdominal surgery in past 30 days | 36 |
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.
| participants | Status at the End of CDI Episode |
|---|---|
| Lost to follow-up | 7 |
| Resolved | 562 |
| Death | 31 |
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.
| participants | Clinical Complication |
|---|---|
| Emergency colectomy performed | 2 |
| Colonoscopy/sigmoidoscopy performed | 2 |
| Colitis or PMC | 83 |
| Toxic megacolon | 1 |
| Hypokalaemia | 23 |
| Hypotension | 1 |
| Dehydration | 17 |
| Septic shock | 9 |
| Peritonitis | 4 |
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
| participants | Recurrence or Not After 2 Months Follow-up |
|---|---|
| Recurrence | 48 |
| No recurrence | 332 |
| Unknown | 220 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Clostridium Difficile Infection | — | — | — |
| Age, Categorical(Participants) | Clostridium Difficile Infection |
|---|---|
| <=18 years | 79 |
| Between 18 and 65 years | 241 |
| >=65 years | 280 |
| Age, Continuous(years) | Clostridium Difficile Infection |
|---|---|
| Median | 63.0 (45.0 to 75.0) |
| Sex: Female, Male(Participants) | Clostridium Difficile Infection |
|---|---|
| Female | 272 |
| Male | 328 |
| Region of Enrollment(participants) | Clostridium Difficile Infection |
|---|---|
| Japan | 48 |
| Australia | 60 |
| China | 64 |
| Hong Kong | 36 |
| India | 2 |
| Indonesia | 7 |
| Philippines | 9 |
| Singapore | 66 |
| Thailand | 44 |
| Vietnam | 64 |
| Malaysia | 2 |
| Korea, Republic of | 99 |
| Taiwan | 99 |
The record gives a start of Mar 2014, a primary completion of Jan 2015 and a completion of Jan 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2016, 1 year 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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