NCT04404582

Brief Summary

The detection of Klebsiella pneumoniae virulence gene and antibiotics resistance gene takes a long time and high cost with equipment requirements. Distinguishing the Klebsiella pneumoniae by gene were late for clinical treatment. Therefore, the investigators aim to study the clinical characteristics of critically ill patients with Klebsiella pneumoniae infection which expressed different drug sensitivity test results.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
546

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

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

January 1, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

4.6 years

First QC Date

May 18, 2020

Last Update Submit

May 22, 2020

Conditions

Drug Resistance

Outcome Measures

Primary Outcomes (2)

  • prognostic indicators

    30-day survival rate

    30 day

  • ICU stays

    the length that patients stay in ICU

    about a mouth

Study Arms (1)

Klebsiella pneumoniae

patients with Klebsiella pneumoniae infection had different results of the drug sensitivity test. we compared the prognosis of these patients.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult whose body fluid were sampled during ICU stay and Klebsiella pneumoniae was detected, followed by drug sensitivity test.

You may qualify if:

  • Adult whose body fluid were sampled during ICU stay and Klebsiella pneumoniae was detected, followed by drug sensitivity test (including reporting the test results after the patient was transferred out of ICU or died).

You may not qualify if:

  • Age were less than 18 years old;
  • Patients stayed in ICU was less than 48 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate senior doctor

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 27, 2020

Study Start

January 1, 2015

Primary Completion

July 31, 2019

Study Completion

February 28, 2020

Last Updated

May 27, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share