- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03598543
Epidemiology of Klebsiella Pneumoniae in China
July 15, 2018 updated by: Jian-cang Zhou M.D., Sir Run Run Shaw Hospital
Klebsiella Pneumoniae Infection in China: Epidemiology, Molecular Characteristics, Treatment, and Outcome
Klebsiella pneumoniae is one of the most common pathogens causing both community-onset and nosocomial infection.
More worse, the emergency of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) had cause the clinical therapy be very difficult.
However, there is not much empirical data as to the prevalence, risk factors, characteristics,outcomes and the rationality of the current therapy for the Klebsiella pneumoniae infection in China.Thus, the study was aimed to investigate the epidemiology and risk factors, characteristics, outcomes and the rationality of the current therapy for the Klebsiella pneumoniae infection in China.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
All the patients with culture positive of Klebsiella pneumoniae were screened and reported to the the clinical doctors and confirmed by them.
And the clinical characteristics of the patiens, such as baseline data, outcomes etc, were recorded.
Finially, to find the prevalence, risk factors, characteristics, outcome and the rationality of the current therapy for the Klebsiella pneumoniae infection in China.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ping Zhang, MD
- Phone Number: +86-571-8600-6142
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310016
- Recruiting
- Sir Run Run Shaw Hospital
-
Contact:
- Ying-zhi Fang
- Phone Number: +86 571 86006987
-
Principal Investigator:
- Yun-song Yu, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Any patients with the age between 18 and 85 years old and with either community or hospital Klebsiella pneumoniae infection.
Description
Inclusion Criteria:
- new confirmed community-onset or noscomial infection of Klebsiella pneumoniae infection
Exclusion Criteria:
- Age<18, or >85 years old; Mixed infection of Klebsiella pneumoniae and other microbes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Carbapenem-Sensitive K. pneumoniae
Any patients with clinical confirmed Carbapenem-Sensitive Klebsiella pneumoniae infection.
|
no intervention, this is an obervational study.
|
Carbapenem-Resistant K. pneumoniae
Patients with clinical confirmed Carbapenem-Resistant Klebsiella pneumoniae infection.
|
no intervention, this is an obervational study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CRKP infection
Time Frame: 6 months
|
Culture postitive results confirmed the infection of CRKP
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yun-song Yu, MD, Zhejiang University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Anticipated)
October 31, 2018
Study Completion (Anticipated)
December 31, 2018
Study Registration Dates
First Submitted
July 15, 2018
First Submitted That Met QC Criteria
July 15, 2018
First Posted (Actual)
July 26, 2018
Study Record Updates
Last Update Posted (Actual)
July 26, 2018
Last Update Submitted That Met QC Criteria
July 15, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRRSH-China-KP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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