Clinical Efficacy of Combination Therapy Based on High-do... | NCT04552444

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

NCT04552444

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Sep 17, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

High-dose Biapenem

Interventions

Biapenem

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2019Actual

Primary Completion Date

Jun 1, 2021Estimated

Completion Date

Aug 1, 2021Estimated

First Submitted Date

Sep 3, 2020

First Submission Date that Met QC Criteria

Sep 16, 2020

First Posted Date

Sep 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2020

Last Update Posted Date

Sep 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Man Huang, Ph.D, Sponsor, Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPrincipal Investigator

Lead Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Biapenem	Drug	In the course of CRKP treatment, double dose biapenem was selected.	the death group the survival group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
28-day mortality		2017.01.01-2021.12.31

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Man Huang, Ph D	Contact	+8613685753994		deter_leung@zju.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital of Zhejiang University Medical College	Recruiting	Hangzhou	Please Select	310000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C065257	biapenem

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided