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

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.

Study Overview

• Status: Unknown
• Conditions: High-dose Biapenem
• Intervention / Treatment: Drug: Biapenem

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Please Select
    • Hangzhou, Please Select, China, 310000
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University Medical College
      • Contact: Man Huang; Phone Number: +8613685753994; Email: deter_leung@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 96 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Most of the patients were from the coastal areas of the Yangtze River, and some of them were exposed to all parts of the country.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
the death group; Through the corresponding treatment, the patients who died within 28 days	Drug: Biapenem; In the course of CRKP treatment, double dose biapenem was selected.
the survival group; Through the corresponding treatment, the patients who survived within 28 days	Drug: Biapenem; In the course of CRKP treatment, double dose biapenem was selected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
28-day mortality	2017.01.01-2021.12.31

Secondary Outcome Measures

Outcome Measure	Time Frame
Clearance rate of pathogenic microorganisms	2017.01.01-2021.12.31
ICU hospitalization days	2017.01.01-2021.12.31

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Clinical Efficacy; High-dose Biapenem; Carbapenem resistance Klebsiella pneumoniae
• Additional Relevant MeSH Terms: Infections; Anti-Infective Agents; Biapenem
• Other Study ID Numbers: SAHZU2017087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No