The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae

Antibiotic Resistant Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03950544
• Other study ID #: STPH-ICU-002
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2019
• Source: Shanghai 10th People's Hospital
• Contact: Ma Lao, master
• Phone: 8613532437896
• Email: 13532437896[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Pneumonia

Intervention

Drug:
• Fosfomycin
Fosfomycin and meropenem
• Tigecycline
Tigecycline and meropenem
• Polymyxin B
Polymyxin B and meropenem

Locations

Country	Name	City	State
China	Shanghai 10th people's hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the fractional inhibitory concentration index (FICI)	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.	24hours-36hours
Secondary	the time-kill assay (TKA)	According to the Clinical and Laboratory Standards Institute,observe the changes of bacterial growth over time after different combination therapy.	36hours-48hours