Clostridium Difficile Infection: the First Report in Sout... | NCT02327520

Studies
Clostridium Difficile Infection: the First Report in Southeast Asia by 2010 Nationwide Study

NCT02327520

Sponsor

King Chulalongkorn Memorial Hospital

Status

Completed

Last Update Posted

Dec 30, 2014Estimated

Enrollment

204,666Actual

Phase

Not provided

Conditions

Clostridium Difficile Infection

Interventions

Colitis with CDI treatment

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2014Actual

First Submitted Date

Dec 22, 2014

First Submission Date that Met QC Criteria

Dec 24, 2014

First Posted Date

Dec 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2014

Last Update Posted Date

Dec 30, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rapat Pittayanon, MD, Gastrointestinal Unit, King Chulalongkorn Memorial Hospital, King Chulalongkorn Memorial HospitalPrincipal Investigator

Lead Sponsor

King Chulalongkorn Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The authors retrieved in-patient medical data, including the expense, from the 2010 Thailand Nationwide Hospital Admission Database, which is part of the National Health Security Office (NHSO). The diagnosis of digestive diseases with any form of colitis listed in the causes, either as principal diagnosis or co-morbidity, coding by the ICD-10 was recorded. The inclusion criteria were: 1) diagnosis of enterocolitis due to Clostridium difficile (ICD10-A07); and 2) age of more than 18 years. If the data was incomplete, the case was excluded. The baseline characteristics, including age, sex, co-morbidity disease and history of endoscopy or surgery, were recorded. The burden of CDI was evaluated by length of hospital stay (LOS), mortality rate, and hospital charge.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

204,666Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colitis with CDI		Patients who diagnosed with CDI will be analysed	Other: Colitis with CDI treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colitis with CDI treatment	Other	All patients will be treated with standard treatment	Colitis with CDI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Death rate and length of hospital stay in CDI during admission	Length of hospital stay(LOS), mortality rate and hospital charge were used as the indicators for evaluating the burden of CDI.	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Hospital charge of CDI	Length of hospital stay(LOS), mortality rate and hospital charge were used as the indicators for evaluating the burden of CDI.	participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients with the diagnosis of Clostridium difficile (ICD10-A07)
Age of more than 18 years.

Exclusion Criteria:

Data incompleted

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The patients with the diagnosis of Clostridium difficile (ICD10-A07) with age of more than 18 years were included.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rapat Pittayanon, MD	King Chulalongkorn Memorial Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003015	Clostridium Infections

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided