Drug Resistance Mechanism of Enterobacteriaceae and Its Strategies

NCT ID: NCT05850871

Last Updated: 2023-05-09

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

NA

Total Enrollment

427 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-06

Study Completion Date

2025-01-31

Brief Summary

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The first aim of this study is to explore the drug resistance mechanism of Enterobacteriaceae bacteria and to evaluate the treatment effect of ceftazidime-avibactam (CAZ-AVI) in combination with aztreonam (ATM) against Metallo-β-lactamases (MBL) producing Enterobacterales in vivo. The investigators then use CRISPR/Cas9 technology to remove Enterobacteriaceae bacteria resistance and virulence genes

Detailed Description

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Clinical information of subjects, including diseases, departments, medication history, days of hospitalization, and treatment outcomes will be collected; Bacterial species names will be identified and drugs sensitivity will be detected; For patients with bloodstream infection of MBL-producing Enterobacterales, ceftazidime-avibactam (CAZ-AVI) was administered at the dose of 2.5 g every 8 hours and aztreonam (ATM) at the dose of 2 g every 8 hours.

The primary outcome measure was 30-day all-cause mortality, while secondary outcomes were clinical failure at day 14 and length of stay (LOS) after bloodstream infection diagnosis. Cox regression analysis, including a propensity score (PS) for receiving CAZ-AVI plus ATM, was conducted to assess the primary and secondary outcomes. The CRISPR/Cas9 gene curation technology was used to eliminate the drug resistance and virulence factors of Enterobacteriaceae in the mouse intestinal colonization model.

Conditions

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Carbapenem-Resistant Enterobacteriaceae Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CAZ/AVI plus Aztreonam

CAZ-AVI was administered at the dose of 2.5 g every 8 hours and ATM at the dose of 2 g every 8 hours

Group Type EXPERIMENTAL

CAZ/AVI plus Aztreonam

Intervention Type DRUG

Samples of the patients will be examined such as the routine blood test, blood culture et al.

Conventional treatment

Other active antibiotics were administered, including colistin, tigecycline, fosfomycin, meropenem.

Group Type ACTIVE_COMPARATOR

Conventional treatment

Intervention Type OTHER

Conventional treatment

Interventions

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CAZ/AVI plus Aztreonam

Samples of the patients will be examined such as the routine blood test, blood culture et al.

Intervention Type DRUG

Conventional treatment

Conventional treatment

Intervention Type OTHER

Other Intervention Names

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ceftzadime avibactam, aztreonam

Eligibility Criteria

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Inclusion Criteria

* Subjects clinically suspected of infection caused by Enterobacterales
* Subjects with bloodstream infection by MBL-producing Enterobacterales

Exclusion Criteria

* Infections caused by viruses, fungi, atypical pathogens, and other non-Enterobacteriaceae bacteria
* subjects who are unwilling to enter the research group
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qianfoshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mingju Hao

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiasheng Zhang, Doctor

Role: STUDY_DIRECTOR

Shandong First Medical University

Locations

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Mingju Hao

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mingju Hao, Doctor

Role: CONTACT

8613012995730

Xiutao Dong, Bachelor

Role: CONTACT

15069061985

Facility Contacts

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Mingju Hao

Role: primary

+8613012995730

Other Identifiers

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JNQH-CT-231001

Identifier Type: -

Identifier Source: org_study_id

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