Klebsiella Pneumoniae InfectionNCT04413305
WGS-guided Tracking and Infection Control Measures of CRKP
A study of Klebsiella Pneumoniae Infection, run by Huashan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Klebsiella Pneumoniae Infection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Infectious department of Huashan Hospital, Fudan University
Shanghai, 200040
Wenhong Zhang, (86)52889999, zhangwenhong@fudan.edu.cn
About this study
Official title: WGS-guided Tracking and Infection Control Measures of Carbapenem-resistant Klebsiella Pneumoniae
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
- Being tested
- screen of CRKP and infection control measure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screen of CRKP and infection control measureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| WGS-based screen and control group | Experimental | 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. Receives: Other: screen of CRKP and infection control measure |
| Non-intervention | No intervention | Non-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the influence of WGS-based screen and control measures on the CRKP occurrence rate
Measured: 2 years
Secondary outcomes (1)
Analysis of transmission pattern and route pre and post WGS-based tracking
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start28 May 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Klebsiella Pneumoniae InfectionStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharmaceuticals (Suzhou) Co. Ltd
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413305
- Sponsor's protocol ID
- KY2019-429KP
- Status last verified
- May 2020
- First submitted
- 28 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WGS-guided Tracking and Infection Control Measures of Carbapenem-resistant Klebsiella Pneumoniae
- ClinicalTrials.gov ID
- NCT04413305
- Acronym / sponsor ID
- KY2019-429KP
- Conditions
- Klebsiella Pneumoniae Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Sumitomo Pharmaceuticals (Suzhou) Co. Ltd
- Study start
- 28 May 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WGS-based screen and control group | Experimental | Other: screen of CRKP and infection control measureFor 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 intervention | –Non-intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screen of CRKP and infection control measureFor 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. | Other | WGS-based screen and control group |
Primary outcome
Evaluate the influence of WGS-based screen and control measures on the CRKP occurrence rate
Time frame: 2 years
1 secondary outcome
Analysis of transmission pattern and route pre and post WGS-based tracking
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Infectious department of Huashan Hospital, Fudan University
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Klebsiella Pneumoniae Infection, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the influence of WGS-based screen and control measures on the CRKP occurrence rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.