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The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae

Sponsor
Shanghai 10th People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03950544
Collaborator
(none)
80
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2019
Anticipated Primary Completion Date :
Aug 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: only meropenem therapy,

this group is only meropenem therapy as a single antibiotic treatment

Drug: Fosfomycin
Fosfomycin and meropenem
Other Names:
  • meropenem

    • Drug: Tigecycline
    Tigecycline and meropenem
    Other Names:
  • meropenem

    • Drug: Polymyxin B
    Polymyxin B and meropenem
    Other Names:
  • meropenem

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the fractional inhibitory concentration index (FICI) [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) [36hours-48hours]

      According to the Clinical and Laboratory Standards Institute,observe the changes of bacterial growth over time after different combination therapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Shanghai 10th people's hospital Shanghai Shanghai China 201300

    Sponsors and Collaborators

    • Shanghai 10th People's Hospital

    Investigators

    • Principal Investigator: Li Hua, master, Shanghai 10th People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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
    Last Update Posted:
    May 15, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Pneumonia
    Meropenem
    Fosfomycin
    Tigecycline
    Polymyxins
    Polymyxin B

    Study Results

    No Results Posted as of May 15, 2019