The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae

Early Phase 1

• Conditions: Antibiotic Resistant Infection
• Interventions: Drug: Fosfomycin; Drug: Tigecycline; Drug: Polymyxin B

• Registration Number: NCT03950544
• Lead Sponsor: Shanghai 10th People's Hospital

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 Timeline

• Study First Submitted: 2018-10-30
• Study Start: 2019-01-01
• Status Verified: 2019-04
• Study First Submitted QC: 2019-05-11
• Last Update Submitted: 2019-05-11
• Study First Posted: 2019-05-15
• Last Update Posted: 2019-05-15
• Primary Completion: 2020-08-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
only meropenem therapy,	Tigecycline	this group is only meropenem therapy as a single antibiotic treatment
only meropenem therapy,	Fosfomycin	this group is only meropenem therapy as a single antibiotic treatment
only meropenem therapy,	Polymyxin B	this group is only meropenem therapy as a single antibiotic treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Shanghai 10th people's hospital; 🇨🇳 Shanghai, Shanghai, China