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The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae

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ClinicalTrials.gov Identifier: NCT03950544
Recruitment Status : 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

Tracking Information
First Submitted Date  ICMJE October 30, 2018
First Posted Date  ICMJE May 15, 2019
Last Update Posted Date May 15, 2019
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae
Official Title  ICMJE How to Optimize the Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae
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
  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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Antibiotic Resistant Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: only meropenem therapy,
this group is only meropenem therapy as a single antibiotic treatment
Interventions:
  • Drug: Fosfomycin
  • Drug: Tigecycline
  • Drug: Polymyxin B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 11, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ma Lao, master 8613532437896 13532437896@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03950544
Other Study ID Numbers  ICMJE STPH-ICU-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sheng Wang MD PhD, Shanghai 10th People's Hospital
Study Sponsor  ICMJE Shanghai 10th People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Li Hua, master Shanghai 10th People's Hospital
PRS Account Shanghai 10th People's Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP