NCT05850871

Drug Resistance Mechanism of Enterobacteriaceae and Its Strategies

Evaluation of Ceftazidime-avibactam Plus Aztreonam in Patients Infected by MBL-producing Enterobacterales and CRISPR/Cas9-based Strategy for Curing Drug-resistant Genes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 427 (estimated)
• Sponsor: Qianfoshan Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Detailed description

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

• Carbapenem-Resistant Enterobacteriaceae Infection

Interventions

Type	Name	Description
DRUG	CAZ/AVI plus Aztreonam	Samples of the patients will be examined such as the routine blood test, blood culture et al.
OTHER	Conventional treatment	Conventional treatment

Timeline

• Start date: 2023-01-06
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2023-05-09
• Last updated: 2023-05-09

Locations

1 site across 1 country: China