Suspended
Clinical Efficacy of Combination Therapy Based on High-dose Biapenem in CRKP Infections
What is being collected
Data Collection
Collected from past medical records and data - RetrospectiveDNA Samples
Who is being recruted
From 14 to 100 Years
+3 Eligibility Criteria
How is the trial designed
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Observational
Study Start: June 2019
Summary
Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Study ContactMan Huang, Ph D
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2019
Actual date on which the first participant was enrolled.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.
Official TitleClinical Efficacy of Combination Therapy Based on High-dose Biapenem in CRKP Infections
Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Study ContactMan Huang, Ph D
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 14 to 100 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
2 inclusion criteria required to participate
Biapenem used for more than 3 days
ICU hospitalized for more than 3 days;
1 exclusion criteria prevent from participating
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
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
The Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, ChinaOpen The Second Affiliated Hospital of Zhejiang University Medical College in Google MapsSuspendedOne Study Center