The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae

How to Optimize the Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03950544

Enrollment

Registered

2019-05-15

Start date

2019-01-01

Completion date

2020-12-31

Last updated

2019-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Resistant Infection

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.

Interventions

DRUGFosfomycin

Fosfomycin and meropenem

DRUGTigecycline

Tigecycline and meropenem

DRUGPolymyxin B

Polymyxin B and meropenem

Study design

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactMa Lao, master

13532437896@163.com8613532437896

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026