The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae

NCT ID: NCT03950544

Last Updated: 2019-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Antibiotic Resistant Infection

Study Design

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Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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only meropenem therapy,

this group is only meropenem therapy as a single antibiotic treatment

Group Type EXPERIMENTAL

Fosfomycin

Intervention Type DRUG

Fosfomycin and meropenem

Tigecycline

Intervention Type DRUG

Tigecycline and meropenem

Polymyxin B

Intervention Type DRUG

Polymyxin B and meropenem

Interventions

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Fosfomycin

Fosfomycin and meropenem

Intervention Type DRUG

Tigecycline

Tigecycline and meropenem

Intervention Type DRUG

Polymyxin B

Polymyxin B and meropenem

Intervention Type DRUG

Other Intervention Names

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meropenem meropenem meropenem

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sheng Wang MD PhD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Hua, master

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

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Shanghai 10th people's hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ma Lao, master

Role: CONTACT

8613532437896

Facility Contacts

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Huanlong Qin, director

Role: primary

18917683138

References

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Du Y, Mu S, Liu Y, Yuan Y, Zhu Y, Ma L, Wang Q, Zhu Z, Liu Y, Wang S. The Genomic Characterization of KPC-Producing Klebsiella pneumoniae from the ICU of a Teaching Hospital in Shanghai, China. Infect Drug Resist. 2022 Jan 11;15:69-81. doi: 10.2147/IDR.S343673. eCollection 2022.

Reference Type DERIVED
PMID: 35046672 (View on PubMed)

Other Identifiers

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STPH-ICU-002

Identifier Type: -

Identifier Source: org_study_id

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