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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03598543
Other study ID # SRRSH-China-KP
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date December 31, 2018

Study information

Verified date July 2018
Source Sir Run Run Shaw Hospital
Contact Ying-zhi FANG, Master
Phone +86 57186006811
Email fyz4817@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Intervention

Other:
no intervention
no intervention, this is an obervational study.

Locations

Country Name City State
China Sir Run Run Shaw Hospital Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary CRKP infection Culture postitive results confirmed the infection of CRKP 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT04413305 - WGS-guided Tracking and Infection Control Measures of CRKP N/A
Completed NCT04959344 - Safety and Immunogenicity of a Klebsiella Pneumoniae Tetravalent Bioconjugate Vaccine (Kleb4V) Phase 1/Phase 2
Not yet recruiting NCT03245632 - Epidemiological Characteristics and Treatment Protocol for Carbapenem-Resistant Klebsiella Pneumoniae in China N/A
Recruiting NCT03891433 - Piperacillin/Tazobactam Versus Carbapenems in Non-bacteremic UTI Due to -ESBL-producing Enterobacteriaceae Phase 4