NCT04552444

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

September 3, 2020

Last Update Submit

September 16, 2020

Conditions

High-dose Biapenem

Keywords

High-dose BiapenemCarbapenem resistance Klebsiella pneumoniaeClinical Efficacy

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    2017.01.01-2021.12.31

Secondary Outcomes (2)

  • Clearance rate of pathogenic microorganisms

    2017.01.01-2021.12.31

  • ICU hospitalization days

    2017.01.01-2021.12.31

Study Arms (2)

the death group

Through the corresponding treatment, the patients who died within 28 days

Drug: Biapenem

the survival group

Through the corresponding treatment, the patients who survived within 28 days

Drug: Biapenem

Interventions

BiapenemDRUG

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

the death groupthe survival group

Eligibility Criteria

Age14 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • ICU hospitalized for more than 3 days;
  • Biapenem used for more than 3 days

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University Medical College

Hangzhou, Please Select, 310000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Klebsiella pneumoniae isolated from sputum, urine and feces of patients

MeSH Terms

Interventions

biapenem

Central Study Contacts

Man Huang, Ph D

CONTACT

+8613685753994deter_leung@zju.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sponsor

Study Record Dates

First Submitted

September 3, 2020

First Posted

September 17, 2020

Study Start

June 1, 2019

Primary Completion

June 1, 2021

Study Completion

August 1, 2021

Last Updated

September 17, 2020

Record last verified: 2020-09

Locations

CN(1)