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

• Conditions: High-dose Biapenem
• Interventions: Drug: Biapenem

• Registration Number: NCT04552444
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-16
• Last Update Submitted: 2020-09-16
• Study First Posted: 2020-09-17
• Last Update Posted: 2020-09-17
• Primary Completion: 2021-06-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
the death group	Biapenem	Through the corresponding treatment, the patients who died within 28 days
the survival group	Biapenem	Through the corresponding treatment, the patients who survived within 28 days

Primary Outcome Measures

Name	Time	Method
28-day mortality	2017.01.01-2021.12.31

Secondary Outcome Measures

Name	Time	Method
Clearance rate of pathogenic microorganisms	2017.01.01-2021.12.31
ICU hospitalization days	2017.01.01-2021.12.31

Trial Locations

Locations (1)

The Second Affiliated Hospital of Zhejiang University Medical College; 🇨🇳 Hangzhou, Please Select, China