Trial Outcomes & Findings for Prospective Observational Study of Clostridium Difficile Infection in Asian Pacific Countries (NCT NCT02223715)

Last Updated: 2016-10-17

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

600 participants

Primary outcome timeframe

At the study at the time of CDI diagnosis enrollment

Results posted on

2016-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Clostridium Difficile Infection To characterize the ｍanagement and outcome of Clostridium Difficile Infection in asian pacific countries
Overall Study STARTED	600
Overall Study COMPLETED	496
Overall Study NOT COMPLETED	104

Reasons for withdrawal

Reasons for withdrawal
Measure	Clostridium Difficile Infection To characterize the ｍanagement and outcome of Clostridium Difficile Infection in asian pacific countries
Overall Study Death	31
Overall Study Lost to Follow-up	73

Baseline Characteristics

Prospective Observational Study of Clostridium Difficile Infection in Asian Pacific Countries

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clostridium Difficile Infection n=600 Participants Patient with Clostridium Difficile Infection
Age, Categorical <=18 years	79 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	241 Participants n=99 Participants
Age, Categorical >=65 years	280 Participants n=99 Participants
Age, Continuous	63.0 years n=99 Participants
Sex: Female, Male Female	272 Participants n=99 Participants
Sex: Female, Male Male	328 Participants n=99 Participants
Region of Enrollment Japan	48 participants n=99 Participants
Region of Enrollment Australia	60 participants n=99 Participants
Region of Enrollment China	64 participants n=99 Participants
Region of Enrollment Hong Kong	36 participants n=99 Participants
Region of Enrollment India	2 participants n=99 Participants
Region of Enrollment Indonesia	7 participants n=99 Participants
Region of Enrollment Philippines	9 participants n=99 Participants
Region of Enrollment Singapore	66 participants n=99 Participants
Region of Enrollment Thailand	44 participants n=99 Participants
Region of Enrollment Vietnam	64 participants n=99 Participants
Region of Enrollment Malaysia	2 participants n=99 Participants
Region of Enrollment Korea, Republic of	99 participants n=99 Participants
Region of Enrollment Taiwan	99 participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Medical History n=600 Participants To characterize the management and outcome of Clostridium Difficile Infection
Patient Demographics Nasogastric tube in past 30 days	107 participants
Patient Demographics Abdominal surgery in past 30 days	36 participants
Patient Demographics Myocardial infarction	54 participants
Patient Demographics Congestive heart failure	46 participants
Patient Demographics Cerebrovascular disease	63 participants
Patient Demographics Peripheral vascular disease	29 participants
Patient Demographics Chronic pulmonary disease	57 participants
Patient Demographics Connective tissue disease	72 participants
Patient Demographics Peptic ulcer disease	69 participants
Patient Demographics Liver disease	76 participants
Patient Demographics Diabetes mellitus	154 participants
Patient Demographics Renal disease	143 participants
Patient Demographics Solid tumor	145 participants
Patient Demographics Leukaemia	44 participants
Patient Demographics Lymphoma	39 participants
Patient Demographics AIDS	3 participants
Patient Demographics IBD	68 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Medical History n=600 Participants To characterize the management and outcome of Clostridium Difficile Infection
Status at the End of CDI Episode Lost to follow-up	7 participants
Status at the End of CDI Episode Resolved	562 participants
Status at the End of CDI Episode Death	31 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Medical History n=600 Participants To characterize the management and outcome of Clostridium Difficile Infection
Clinical Complication Emergency colectomy performed	2 participants
Clinical Complication Colonoscopy/sigmoidoscopy performed	2 participants
Clinical Complication Colitis or PMC	83 participants
Clinical Complication Toxic megacolon	1 participants
Clinical Complication Hypokalaemia	23 participants
Clinical Complication Hypotension	1 participants
Clinical Complication Dehydration	17 participants
Clinical Complication Septic shock	9 participants
Clinical Complication Peritonitis	4 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Medical History n=600 Participants To characterize the management and outcome of Clostridium Difficile Infection
Recurrence or Not After 2 Months Follow-up Recurrence	48 participants
Recurrence or Not After 2 Months Follow-up No recurrence	332 participants
Recurrence or Not After 2 Months Follow-up Unknown	220 participants

Adverse Events

Clostridium Difficile Infection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director, Yoshitaka Kotobuki, Mr

Otsuka Pharmaceutical Co., LTD.

Phone: +81-3-6361-7366

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place