Epidemiological Characteristics and Treatment Protocol fo... | NCT03245632

Studies
Epidemiological Characteristics and Treatment Protocol for Carbapenem-Resistant Klebsiella Pneumoniae in China

NCT03245632

Sponsor

Sir Run Run Shaw Hospital

Status

Unknown status

Last Update Posted

Aug 10, 2017Actual

Enrollment

800Estimated

Phase

Not provided

Conditions

Klebsiella Pneumoniae Infection

Interventions

Carbapenem-Resistant Klebsiella pneumoniae

Countries

China

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

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2017Estimated

Primary Completion Date

Jul 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Aug 6, 2017

First Submission Date that Met QC Criteria

Aug 9, 2017

First Posted Date

Aug 10, 2017Actual

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

Aug 9, 2017

Last Update Posted Date

Aug 10, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Klebsiella pneumoniae is one of the most common pathogens causing nosocomial infection. Recently, the emergency of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) had cause the clinical therapy be very difficult. However, there is not much empirical data as to the prevalence, risk factors, characteristics, and the rationality of the current therapy for the CRKP infection. Thus, the study was aimed to investigate the epidemiology and risk factors, characteristics, and the rationality of the current therapy for the CRKP infection.

Detailed Description

All the patients with culture positive of Klebsiella pneumoniae were screened and reported to the the clinical doctors and confirmed by them. And the clinical characteristics of the patiens, such as baseline data, outcomes etc, were recorded. Finially, to find the prevalence, risk factors, characteristics, and the rationality of the current therapy for the CRKP infection

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carbapenem-Resistant K. pneumoniae		Patients with clinical confirmed Carbapenem-Resistant Klebsiella pneumoniae infection.	Other: Carbapenem-Resistant Klebsiella pneumoniae
Carbapenem-Sensitive K. pneumoniae		Any patients with clinical confirmed Carbapenem-Sensitive Klebsiella pneumoniae infection.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carbapenem-Resistant Klebsiella pneumoniae	Other	no intervention, this is an obervational study.	Carbapenem-Resistant K. pneumoniae

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CRKP infection	Culture postitive results confirmed the infection of CRKP	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

new confirmed noscomial infection of CRKP

Exclusion Criteria:

Age<18, or >85 years old; Mixed infection of CRKP and other microbes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients admitted to all study hospitals and met the aboved eligibility

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ying-zhi FANG, Master	Contact	+86 57186006811		fyz4817@126.com

Overall Officials

Name	Affiliation	Role
Yun-song YU, Doctor	Sir Run Run Shaw Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sir Run Run Shaw Hospital		Hangzhou	Zhejiang	310016	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

For the time, we are not yet make determined to take the IPD plan

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided