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The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae

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: NCT03950544
Recruitment Status : Unknown
Verified April 2019 by Sheng Wang MD PhD, Shanghai 10th People's Hospital.
Recruitment status was:  Recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sheng Wang MD PhD, Shanghai 10th People's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Antibiotic Resistant Infection Drug: Fosfomycin Drug: Tigecycline Drug: Polymyxin B Early Phase 1

Detailed Description:
  1. Collect the BALF from patients diagnosed with CRKP infection in surgical intensive care unit（SICU）of Shanghai 10th people's hospital.
  2. 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: How to Optimize the Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Meropenem

Arms and Interventions
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Arm Intervention/treatment
Experimental: only meropenem therapy,
this group is only meropenem therapy as a single antibiotic treatment
 Drug: Fosfomycin
Fosfomycin and meropenem
Other Name: meropenem

Drug: Tigecycline
Tigecycline and meropenem
Other Name: meropenem

Drug: Polymyxin B
Polymyxin B and meropenem
Other Name: meropenem


Outcome Measures
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Primary Outcome Measures :
  1. the fractional inhibitory concentration index (FICI) [ Time Frame: 24hours-36hours ]

    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 :
  1. the time-kill assay (TKA) [ Time Frame: 36hours-48hours ]
    According to the Clinical and Laboratory Standards Institute,observe the changes of bacterial growth over time after different combination therapy.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT03950544


Contacts
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Contact: Ma Lao, master 8613532437896 13532437896@163.com

Locations
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China, Shanghai
Shanghai 10th people's hospital Recruiting
Shanghai, Shanghai, China, 201300
Contact: Huanlong Qin, director    18917683138    wangsheng@tongji.edu.cn   
Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
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Principal Investigator: Li Hua, master Shanghai 10th People's Hospital
More Information
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Responsible Party: Sheng Wang MD PhD, Director, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT03950544    
Other Study ID Numbers: STPH-ICU-002
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Meropenem
Fosfomycin
Tigecycline
 Polymyxins
Polymyxin B
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action