Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04552444
Other study ID # SAHZU2017087
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date August 1, 2021

Study information

Verified date September 2020
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Man Huang, Ph D
Phone +8613685753994
Email deter_leung@zju.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Carbapenem resistance is a high mortality rate of Klebsiella pneumoniae infection. It has been proved that high-dose carbapenem can reduce mortality and has a certain clinical effect. In this study, a high dose of biapenem was compared to determine whether it had a similar effect than meropenem.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date August 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 14 Years to 100 Years
Eligibility Inclusion Criteria:

- ICU hospitalized for more than 3 days;

- Biapenem used for more than 3 days

Exclusion Criteria:

- Patients who refuse to be included in the group or pregnant women or under the age of 14 or ICU hospitalized for less than 3 days

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Biapenem
In the course of CRKP treatment, double dose biapenem was selected.

Locations

Country Name City State
China The Second Affiliated Hospital of Zhejiang University Medical College Hangzhou Please Select

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 28-day mortality 2017.01.01-2021.12.31
Secondary Clearance rate of pathogenic microorganisms 2017.01.01-2021.12.31
Secondary ICU hospitalization days 2017.01.01-2021.12.31