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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04404582
Other study ID # K2019-06-031
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date February 28, 2020

Study information

Verified date May 2020
Source Fujian Provincial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Clinical data of adult patients in integrated ICUs of 6 hospitals of Fujian Province China from January 2015 to July 2019 were collected, who had been examined for sputum, urine, blood, pleural effusion, ascites, cerebrospinal fluid and wound secretions and other body fluid samples. And the results showed that Klebsiella pneumoniae was positive, including demographic data, underlying disease status, drug sensitivity test, infection-related indicators, life support, prognostic indicators.


Recruitment information / eligibility

Status Completed
Enrollment 546
Est. completion date February 28, 2020
Est. primary completion date July 31, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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).

Exclusion Criteria:

- Age were less than 18 years old;

- Patients stayed in ICU was less than 48 hours.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fujian Provincial Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary prognostic indicators 30-day survival rate 30 day
Primary ICU stays the length that patients stay in ICU about a mouth
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