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The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae

Primary Purpose

Antibiotic Resistant Infection

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Fosfomycin
Tigecycline
Polymyxin B
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Antibiotic Resistant Infection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age from 18 to 90.
  • infected with CRKP firstly .

Exclusion Criteria:

  • APACHE II score > 35
  • Vital signs are unstable
  • Unable to tolerate fiberoptic bronchoscopy

Sites / Locations

  • Shanghai 10th people's hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

only meropenem therapy,

Arm Description

this group is only meropenem therapy as a single antibiotic treatment

Outcomes

Primary Outcome Measures

the fractional inhibitory concentration index (FICI)
By checkerboard method and microdilution broth method,get the minimal inhibitory concentration (MICS) of two antibiotics,then calculate the fractional inhibitory concentration (FIC) index according to MIC results. Evaluation index: FIC=0.5 , coordinating effect. 0.5 < FIC <1, adding effect; 1 < FIC <2, irrelevant.

Secondary Outcome Measures

the time-kill assay (TKA)
According to the Clinical and Laboratory Standards Institute,observe the changes of bacterial growth over time after different combination therapy.

Full Information

First Posted
October 30, 2018
Last Updated
May 11, 2019
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03950544
Brief Title
The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae
Official Title
How to Optimize the Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The infection of carbapenem resistant klebsiella pneumoniae (CRKP) is increasingly serious.Based on the early experimental basis and relevant research background,this study intends to separate and purify the CRKP from the bronchoalveolar lavage fluid (BALF) of the clinical patients.Designed by checkerboard assay and time-kill assay(TKA)，this study can explore the best combination therapy based on carbapenems.
Detailed Description
Collect the BALF from patients diagnosed with CRKP infection in surgical intensive care unit（SICU）of Shanghai 10th people's hospital. Separate and purify the BALF. Divide each CRKP into four treatment groups based on meropenem. 3.1 By checkerboard method and microdilution broth method,get the minimal inhibitory concentration (MICS) of two antibiotics,then calculate the fractional inhibitory concentration (FIC) index according to MIC results. 3.2 Observe the effect of two antibiotics on the growth of CRKP by TKA. 4.By the above two invitro experiments, analyze the data of the experimental results and get the best combination therapy based on carbapenems.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic Resistant Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
only meropenem therapy,
Arm Type
Experimental
Arm Description
this group is only meropenem therapy as a single antibiotic treatment
Intervention Type
Drug
Intervention Name(s)
Fosfomycin
Other Intervention Name(s)
meropenem
Intervention Description
Fosfomycin and meropenem
Intervention Type
Drug
Intervention Name(s)
Tigecycline
Other Intervention Name(s)
meropenem
Intervention Description
Tigecycline and meropenem
Intervention Type
Drug
Intervention Name(s)
Polymyxin B
Other Intervention Name(s)
meropenem
Intervention Description
Polymyxin B and meropenem
Primary Outcome Measure Information:
Title
the fractional inhibitory concentration index (FICI)
Description
By checkerboard method and microdilution broth method,get the minimal inhibitory concentration (MICS) of two antibiotics,then calculate the fractional inhibitory concentration (FIC) index according to MIC results. Evaluation index: FIC=0.5 , coordinating effect. 0.5 < FIC <1, adding effect; 1 < FIC <2, irrelevant.
Time Frame
24hours-36hours
Secondary Outcome Measure Information:
Title
the time-kill assay (TKA)
Description
According to the Clinical and Laboratory Standards Institute,observe the changes of bacterial growth over time after different combination therapy.
Time Frame
36hours-48hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age from 18 to 90. infected with CRKP firstly . Exclusion Criteria: APACHE II score > 35 Vital signs are unstable Unable to tolerate fiberoptic bronchoscopy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ma Lao, master
Phone
8613532437896
Email
13532437896@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Hua, master
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai 10th people's hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201300
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huanlong Qin, director
Phone
18917683138
Email
wangsheng@tongji.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35046672
Citation
Du Y, Mu S, Liu Y, Yuan Y, Zhu Y, Ma L, Wang Q, Zhu Z, Liu Y, Wang S. The Genomic Characterization of KPC-Producing Klebsiella pneumoniae from the ICU of a Teaching Hospital in Shanghai, China. Infect Drug Resist. 2022 Jan 11;15:69-81. doi: 10.2147/IDR.S343673. eCollection 2022.
Results Reference
derived

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The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae

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