NCT03598543

Brief Summary

Klebsiella pneumoniae is one of the most common pathogens causing both community-onset and nosocomial infection. More worse, 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,outcomes and the rationality of the current therapy for the Klebsiella pneumoniae infection in China.Thus, the study was aimed to investigate the epidemiology and risk factors, characteristics, outcomes and the rationality of the current therapy for the Klebsiella pneumoniae infection in China.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 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

June 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

July 15, 2018

Last Update Submit

July 15, 2018

Conditions

Klebsiella Pneumoniae Infection

Outcome Measures

Primary Outcomes (1)

  • CRKP infection

    Culture postitive results confirmed the infection of CRKP

    6 months

Study Arms (2)

Carbapenem-Sensitive K. pneumoniae

Any patients with clinical confirmed Carbapenem-Sensitive Klebsiella pneumoniae infection.

Other: no intervention

Carbapenem-Resistant K. pneumoniae

Patients with clinical confirmed Carbapenem-Resistant Klebsiella pneumoniae infection.

Other: no intervention

Interventions

no interventionOTHER

no intervention, this is an obervational study.

Carbapenem-Resistant K. pneumoniaeCarbapenem-Sensitive K. pneumoniae

Eligibility Criteria

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

Any patients with the age between 18 and 85 years old and with either community or hospital Klebsiella pneumoniae infection.

You may qualify if:

  • \- new confirmed community-onset or noscomial infection of Klebsiella pneumoniae infection

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

RECRUITING

Study Officials

  • Yun-song Yu, MD

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying-zhi FANG, Master

CONTACT

+86 57186006811fyz4817@126.com

Ping Zhang, MD

CONTACT

+86-571-8600-6142

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

July 15, 2018

First Posted

July 26, 2018

Study Start

June 1, 2018

Primary Completion

October 31, 2018

Study Completion

December 31, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

CN(1)