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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04552444
Recruitment Status : Unknown
Verified September 2020 by Man Huang, Ph.D, Second Affiliated Hospital, School of Medicine, Zhejiang University.
Recruitment status was:  Recruiting
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Man Huang, Ph.D, 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.

Condition or disease Intervention/treatment
High-dose Biapenem Drug: Biapenem

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Clinical Efficacy of Combination Therapy Based on High-dose Biapenem in CRKP Infections
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 28-day mortality [ Time Frame: 2017.01.01-2021.12.31 ]

Secondary Outcome Measures :
  1. Clearance rate of pathogenic microorganisms [ Time Frame: 2017.01.01-2021.12.31 ]
  2. ICU hospitalization days [ Time Frame: 2017.01.01-2021.12.31 ]

Biospecimen Retention:   Samples With DNA
Klebsiella pneumoniae isolated from sputum, urine and feces of patients


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04552444


Contacts
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Contact: Man Huang, Ph D +8613685753994 deter_leung@zju.edu.cn

Locations
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China, Please Select
The Second Affiliated Hospital of Zhejiang University Medical College Recruiting
Hangzhou, Please Select, China, 310000
Contact: Man Huang    +8613685753994    deter_leung@zju.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
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Responsible Party: Man Huang, Ph.D, Sponsor, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04552444    
Other Study ID Numbers: SAHZU2017087
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Man Huang, Ph.D, Second Affiliated Hospital, School of Medicine, Zhejiang University:
High-dose Biapenem
Carbapenem resistance Klebsiella pneumoniae
Clinical Efficacy
Additional relevant MeSH terms:
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Infections
Biapenem
Anti-Infective Agents