Drug Resistance Mechanism of Enterobacteriaceae and Its Strategies

NCT05850871 | Unknown

• 1 other identifier: JNQH-CT-231001
• Study Type: interventional
• Target: 427
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carbapenem-Resistant Enterobacteriaceae Infection

Keywords

carbapenem resistance; Enterobacteriaceae; CRISPR/Cas9

Outcome Measures

Primary Outcomes (3)

• 30-day all-cause mortality

  The primary outcome measure was 30-day all-cause mortality

  two years

• clinical failure at day 14

  severe comorbidities, mechanical ventilation or septic shock at day 14

  two years

• length of stay after diagnosis

  length of stay (LOS) after blood stream infection diagnosis

  two years

Secondary Outcomes (1)

• Positive rate of Metallo-β-lactamases (MBL) producing Enterobacterales

  two years

Other Outcomes (1)

• Curation index as assessed by MBL producing Enterobacterales compared with MBL negative Enterobacterales.

  two years

Study Arms (2)

CAZ/AVI plus Aztreonam

EXPERIMENTAL

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

Drug: CAZ/AVI plus Aztreonam

Conventional treatment

ACTIVE COMPARATOR

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

Other: Conventional treatment

Interventions

CAZ/AVI plus Aztreonam DRUG

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

Also known as: ceftzadime avibactam, aztreonam

CAZ/AVI plus Aztreonam

Conventional treatment OTHER

Conventional treatment

Conventional treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Mingju Hao

Jinan, Shandong, 250014, China

RECRUITING

MeSH Terms

Interventions

Aztreonam

Intervention Hierarchy (Ancestors)

Monobactams; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jiasheng Zhang, Doctor

  Shandong First Medical University

  STUDY DIRECTOR

Central Study Contacts

Mingju Hao, Doctor

CONTACT

8613012995730; haomingju@163.com

Xiutao Dong, Bachelor

CONTACT

15069061985; 3185573520@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 9, 2023
• Study Start: January 6, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: May 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)