WGS-guided Tracking and Infection Control Measures of CRKP

Klebsiella Pneumoniae Infection Clinical Trial

Official title:

WGS-guided Tracking and Infection Control Measures of Carbapenem-resistant Klebsiella Pneumoniae

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04413305
• Other study ID #: KY2019-429KP
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: May 2020
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to investigate the effect of the infection control measures based on the active screening of carbapenem-resistant Klebsiella pneumoniae and whole-genome based tracking and surveillance though the hospital.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The patient was admitted to the ICU of neurosurgery in the west hospital of huashan hospital affiliated to fudan university from September 2019 to September 2021, or transferred from the ICU of another hospital

2. The patient is more than 18 years old and less than 80 years old, regardless of gender.

3. Informed consent of the patient;

Exclusion Criteria:

1. Patients participating in other clinical trials at the same time

2. Pregnant

4. People who will affect the outcome of the study: whose specimens could not be received or not enough for testing

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Klebsiella Infections
• Klebsiella Pneumoniae Infection
• Pneumonia

Intervention

Other:
• screen of CRKP and infection control measure
For intervention group, we screen admitted patients for carbapenem-resistant Klebsiella pneumoniae and carry out 'Bundle' infection and control measures. When outbreak or tranmission of CRKP was observed, we take whole-genome sequencing to track origin and transmission route to decease CRKP rate.

Locations

Country	Name	City	State
China	Infectious department of Huashan Hospital, Fudan University	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Huashan Hospital	Sumitomo Pharmaceuticals (Suzhou) Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the influence of WGS-based screen and control measures on the CRKP occurrence rate		2 years
Secondary	Analysis of transmission pattern and route pre and post WGS-based tracking		2 years