Epidemiological Characteristics and Treatment Protocol for Carbapenem-Resistant Klebsiella Pneumoniae in China

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.

Study Overview

• Status: Unknown
• Conditions: Klebsiella Pneumoniae Infection
• Intervention / Treatment: Other: Carbapenem-Resistant Klebsiella pneumoniae

Detailed Description

All the patients with culture positive of Klebsiella pneumoniae were screened and reported to the the clinical doctors and confirmed by them. And the clinical characteristics of the patiens, such as baseline data, outcomes etc, were recorded. Finially, to find the prevalence, risk factors, characteristics, and the rationality of the current therapy for the CRKP infection

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• new confirmed noscomial infection of CRKP

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Carbapenem-Sensitive K. pneumoniae; Any patients with clinical confirmed Carbapenem-Sensitive Klebsiella pneumoniae infection.
Carbapenem-Resistant K. pneumoniae; Patients with clinical confirmed Carbapenem-Resistant Klebsiella pneumoniae infection.	Other: Carbapenem-Resistant Klebsiella pneumoniae; no intervention, this is an obervational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRKP infection	Culture postitive results confirmed the infection of CRKP	7 days

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital
• Investigators: Principal Investigator: Yun-song YU, Doctor, Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2017
• Primary Completion (ANTICIPATED): July 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: August 6, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (ACTUAL): August 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2017
• Last Update Submitted That Met QC Criteria: August 9, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Pneumonia; Klebsiella Infections
• Other Study ID Numbers: SRRSH-CRKP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: For the time, we are not yet make determined to take the IPD plan

Drug and device information, study documents

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