Actively Recruiting
Aztreonam-Avibactam Real World Study Against Metallo-b2-lactamase-Producing Carbapenem-Resistant Enterobacterales
Led by Sir Run Run Shaw Hospital · Updated on 2026-03-23
100
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sir Run Run Shaw Hospital
Lead Sponsor
T
The First Affiliated Hospital of Nanchang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the real-world use of a new antibiotic combination called Aztreonam-Avibactam (ATM-AVI) in adult patients hospitalized in China with infections caused by metallo-b2-lactamase-producing carbapenem-resistant Enterobacterales (MBL-producing CRE). These infections are resistant to common antibiotics, making them hard to treat. The study aims to understand how well ATM-AVI works outside of initial testing, including its effectiveness, patient characteristics, and impact on hospital stays. This observational study will include about 100 adult patients from around 30 hospitals in China who have been treated with ATM-AVI for at least 24 hours. The study will gather data both retrospectively from past patient records and prospectively with patient consent. Researchers will review how the drug was used and collect information about the infections and patient outcomes at different time points. Participants' medical records will be examined to gather details such as patient demographics, infection type, treatment timing, laboratory test results, and hospital resource use. Doctors will assess patient progress after 5 days of treatment, at the end of treatment, and during a follow-up visit to determine if the infection has cleared. The study will also monitor clinical success or failure and any deaths during or after treatment. The study runs from December 2025 to July 2027.
CONDITIONS
Brief Title
Real-World Effectiveness of Aztreonam-Avibactam Against MBL-Producing CRE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Hospitalized with confirmed complicated intra-abdominal infection or hospital-acquired/ventilator-associated pneumonia
- Confirmed infection with metallo-b2-lactamase-producing carbapenem-resistant Enterobacterales (MBL-producing CRE)
- Received on-label use of Aztreonam-Avibactam treatment for at least 24 hours
- Informed consent obtained or waived
You will not qualify if you...
- Confirmed or suspected infection caused by Gram-negative species not expected to respond to Aztreonam-Avibactam
- Currently enrolled in an interventional clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 4 weeks
Participants receive Aztreonam-Avibactam treatment for MBL-producing CRE infections.
Visits at enrollment and end of treatment
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
2
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310016
Not Yet Recruiting
Research Team
Y
Yunsong Yu, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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