WGS-guided Tracking and Infection Control Measures of CRKP

NCT ID: NCT04413305

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-28
• Study Completion Date: 2021-09-30

Brief 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.

Conditions

Klebsiella Pneumoniae Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

WGS-based screen and control group

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.

Group Type: EXPERIMENTAL

screen of CRKP and infection control measure

Intervention Type: OTHER

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.

Non-intervention

Non-intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharmaceuticals (Suzhou) Co. Ltd

UNKNOWN

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wen-hong Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Infectious department of Huashan Hospital, Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Wenhong Zhang

Role: primary

zhangwenhong@fudan.edu.cn

(86)52889999

Other Identifiers

KY2019-429KP

Identifier Type: -

Identifier Source: org_study_id