Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Epidemiology of Klebsiella Pneumoniae in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03598543
Recruitment Status : Unknown
Verified July 2018 by Jian-cang Zhou M.D., Sir Run Run Shaw Hospital.
Recruitment status was:  Recruiting
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Jian-cang Zhou M.D., Sir Run Run Shaw Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment
Klebsiella Pneumoniae Infection Other: no intervention

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Klebsiella Pneumoniae Infection in China: Epidemiology, Molecular Characteristics, Treatment, and Outcome
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Carbapenem-Sensitive K. pneumoniae
Any patients with clinical confirmed Carbapenem-Sensitive Klebsiella pneumoniae infection.
 Other: no intervention
no intervention, this is an obervational study.
Carbapenem-Resistant K. pneumoniae
Patients with clinical confirmed Carbapenem-Resistant Klebsiella pneumoniae infection.
 Other: no intervention
no intervention, this is an obervational study.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. CRKP infection [ Time Frame: 6 months ]
    Culture postitive results confirmed the infection of CRKP


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598543


Contacts
Layout table for location contacts
Contact: Ying-zhi FANG, Master +86 57186006811 fyz4817@126.com
Contact: Ping Zhang, MD +86-571-8600-6142

Locations
Layout table for location information
China, Zhejiang
Sir Run Run Shaw Hospital Recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Ying-zhi Fang    +86 571 86006987      
Principal Investigator: Yun-song Yu, M.D.         
Sponsors and Collaborators
Sir Run Run Shaw Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yun-song Yu, MD Zhejiang University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jian-cang Zhou M.D., Prof., Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier: NCT03598543    
Other Study ID Numbers: SRRSH-China-KP
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Pneumonia
Klebsiella Infections
Respiratory Tract Infections
Lung Diseases
 Respiratory Tract Diseases
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses