WGS-guided Tracking and Infection Control Measures of CRKP
1 other identifier
interventional
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2020
CompletedStudy Start
First participant enrolled
May 28, 2020
CompletedFirst Posted
Study publicly available on registry
June 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedJune 2, 2020
May 1, 2020
1.3 years
May 28, 2020
May 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the influence of WGS-based screen and control measures on the CRKP occurrence rate
2 years
Secondary Outcomes (1)
Analysis of transmission pattern and route pre and post WGS-based tracking
2 years
Study Arms (2)
WGS-based screen and control group
EXPERIMENTALFor 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
NO INTERVENTIONNon-intervention
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- The patient is more than 18 years old and less than 80 years old, regardless of gender.
- Informed consent of the patient;
You may not qualify if:
- Patients participating in other clinical trials at the same time
- Pregnant
- \. People who will affect the outcome of the study: whose specimens could not be received or not enough for testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
- Sumitomo Pharmaceuticals (Suzhou) Co. Ltdcollaborator
Study Sites (1)
Infectious department of Huashan Hospital, Fudan University
Shanghai, 200040, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 28, 2020
First Posted
June 2, 2020
Study Start
May 28, 2020
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
June 2, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share