NCT03245632

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

August 6, 2017

Last Update Submit

August 9, 2017

Conditions

Klebsiella Pneumoniae Infection

Outcome Measures

Primary Outcomes (1)

  • CRKP infection

    Culture postitive results confirmed the infection of CRKP

    7 days

Study Arms (2)

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

Carbapenem-Resistant Klebsiella pneumoniaeOTHER

no intervention, this is an obervational study.

Carbapenem-Resistant K. pneumoniae

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • new confirmed noscomial infection of CRKP

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

Location

Study Officials

  • Yun-song YU, Doctor

    Sir Run Run Shaw Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying-zhi FANG, Master

CONTACT

+86 57186006811fyz4817@126.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

August 6, 2017

First Posted

August 10, 2017

Study Start

August 1, 2017

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

August 10, 2017

Record last verified: 2017-08

Locations

CN(1)