Back to resultsWGS-guided Tracking and Infection Control Measures of CRKP
Primary Purpose
Klebsiella Pneumoniae Infection
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
screen of CRKP and infection control measure
Sponsored by
About this trial
This is an interventional screening trial for Klebsiella Pneumoniae Infection
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- Patients participating in other clinical trials at the same time
- Pregnant
4. People who will affect the outcome of the study: whose specimens could not be received or not enough for testing
Sites / Locations
- Infectious department of Huashan Hospital, Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
WGS-based screen and control group
Non-intervention
Arm Description
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
Outcomes
Primary Outcome Measures
Evaluate the influence of WGS-based screen and control measures on the CRKP occurrence rate
Secondary Outcome Measures
Analysis of transmission pattern and route pre and post WGS-based tracking
Full Information
NCT ID
NCT04413305
First Posted
May 28, 2020
Last Updated
May 28, 2020
Sponsor
Huashan Hospital
Collaborators
Sumitomo Pharmaceuticals (Suzhou) Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04413305
Brief Title
WGS-guided Tracking and Infection Control Measures of CRKP
Official Title
WGS-guided Tracking and Infection Control Measures of Carbapenem-resistant Klebsiella Pneumoniae
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 28, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
Collaborators
Sumitomo Pharmaceuticals (Suzhou) Co. Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Klebsiella Pneumoniae Infection
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WGS-based screen and control group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-intervention
Arm Type
No Intervention
Arm Description
Non-intervention
Intervention Type
Other
Intervention Name(s)
screen of CRKP and infection control measure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the influence of WGS-based screen and control measures on the CRKP occurrence rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Analysis of transmission pattern and route pre and post WGS-based tracking
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
Patients participating in other clinical trials at the same time
Pregnant
4. People who will affect the outcome of the study: whose specimens could not be received or not enough for testing
Facility Information:
Facility Name
Infectious department of Huashan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhong Zhang
Phone
(86)52889999
Email
zhangwenhong@fudan.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
WGS-guided Tracking and Infection Control Measures of CRKP
We'll reach out to this number within 24 hrs