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Epidemiological Characteristics and Treatment Protocol for Carbapenem-Resistant Klebsiella Pneumoniae in China

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ClinicalTrials.gov Identifier: NCT03245632
Recruitment Status : Not yet recruiting
First Posted : August 10, 2017
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Jian-cang Zhou M.D., Sir Run Run Shaw Hospital

Brief Summary:
Klebsiella pneumoniae is one of the most common pathogens causing nosocomial infection. Recently, 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, and the rationality of the current therapy for the CRKP infection. Thus, the study was aimed to investigate the epidemiology and risk factors, characteristics, and the rationality of the current therapy for the CRKP infection.

Condition or disease Intervention/treatment
Klebsiella Pneumoniae Infection Other: Carbapenem-Resistant Klebsiella pneumoniae

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, and the rationality of the current therapy for the CRKP infection

Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Epidemiological Characteristics and Treatment Protocol for Carbapenem-Resistant Klebsiella Pneumoniae in China
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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

Carbapenem-Sensitive K. pneumoniae
Any patients with clinical confirmed Carbapenem-Sensitive Klebsiella pneumoniae infection.



Primary Outcome Measures :
  1. CRKP infection [ Time Frame: 7 days ]
    Culture postitive results confirmed the infection of CRKP



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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
Consecutive patients admitted to all study hospitals and met the aboved eligibility
Criteria

Inclusion Criteria:

  • new confirmed noscomial infection of CRKP

Exclusion Criteria:

  • Age<18, or >85 years old; Mixed infection of CRKP and other microbes

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): NCT03245632


Contacts
Contact: Ying-zhi FANG, Master +86 57186006811 fyz4817@126.com

Locations
China, Zhejiang
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310016
Sponsors and Collaborators
Sir Run Run Shaw Hospital
Investigators
Principal Investigator: Yun-song YU, Doctor Sir Run Run Shaw Hospital

Responsible Party: Jian-cang Zhou M.D., Prof., Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier: NCT03245632     History of Changes
Other Study ID Numbers: SRRSH-CRKP
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: For the time, we are not yet make determined to take the IPD plan

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pneumonia
Klebsiella Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections