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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03245632
Other study ID # SRRSH-CRKP
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 6, 2017
Last updated August 9, 2017
Start date August 2017
Est. completion date December 2019

Study information

Verified date August 2017
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 [Patient Registry]

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 800
Est. completion date December 2019
Est. primary completion date July 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- new confirmed noscomial infection of CRKP

Exclusion Criteria:

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

Study Design


Intervention

Other:
Carbapenem-Resistant Klebsiella pneumoniae
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 7 days
See also
  Status Clinical Trial Phase
Recruiting NCT04413305 - WGS-guided Tracking and Infection Control Measures of CRKP N/A
Recruiting NCT03598543 - Epidemiology of Klebsiella Pneumoniae in China
Completed NCT04959344 - Safety and Immunogenicity of a Klebsiella Pneumoniae Tetravalent Bioconjugate Vaccine (Kleb4V) Phase 1/Phase 2
Recruiting NCT03891433 - Piperacillin/Tazobactam Versus Carbapenems in Non-bacteremic UTI Due to -ESBL-producing Enterobacteriaceae Phase 4