Clinical Characteristics for the Critical Ill Patients With Klebsiella Pneumoniae Infection

Analysis of the Clinical Characteristics for the Critical Ill Patients With Klebsiella Pneumoniae Infection: A Multi-center Research in the Intensive Care Units

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.

Study Overview

• Status: Completed
• Conditions: Drug Resistance

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 546

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prognostic indicators	30-day survival rate	30 day
ICU stays	the length that patients stay in ICU	about a mouth

Collaborators and Investigators

• Sponsor: Fujian Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: K2019-06-031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No