Clinical Efficacy of Combination Therapy Based on High-dose Biapenem in CRKP Infections

High-dose Biapenem Clinical Trial

Official title:

Clinical Efficacy of Combination Therapy Based on High-dose Biapenem in CRKP Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04552444
• Other study ID #: SAHZU2017087
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• High-dose Biapenem
• Infection

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