Clinical trial
Evaluation of Ceftazidime-avibactam Plus Aztreonam in Patients Infected by MBL-producing Enterobacterales and CRISPR/Cas9-based Strategy for Curing Drug-resistant Genes
Name
JNQH-CT-231001
Description
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
Trial arms
Trial start
2023-01-06
Estimated PCD
2025-01-31
Trial end
2025-01-31
Status
Recruiting
Treatment
CAZ/AVI plus Aztreonam
Samples of the patients will be examined such as the routine blood test, blood culture et al.
Arms:
CAZ/AVI plus Aztreonam
Other names:
ceftzadime avibactam, aztreonam
Conventional treatment
Conventional treatment
Arms:
Conventional treatment
Size
427
Primary endpoint
30-day all-cause mortality
two years
clinical failure at day 14
two years
length of stay after diagnosis
two years
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 427, 'type': 'ESTIMATED'}}
Updated at
2023-05-09
1 organization
1 product
1 indication
Organization
Qianfoshan HospitalProduct
CAZ/AVI + Aztreonam