Actively Recruiting
Sequential Infusion Versus Concomitant Infusion of Ceftazidime-Avibactam Combined With Aztreonam for Treating Metallo-β-lactamase-producing Carbapenem-resistant Gram-negative Bacterial Infections
Led by Jing Zhou · Updated on 2026-03-17
144
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Metallo-β-lactamase-producing carbapenem-resistant Gram-negative bacteria (MBL-CR-GNB) are a serious global health threat due to their ability to break down almost all β-lactam antibiotics. Current inhibitors like avibactam cannot stop metallo-β-lactamases, limiting treatment options. Researchers are studying the combination of ceftazidime-avibactam with aztreonam, which works together to fight these infections. This phase 4 clinical trial aims to compare different infusion methods for this combination in patients with complicated infections caused by MBL-CR-GNB. Participants will receive either a 3-hour simultaneous intravenous infusion of ceftazidime-avibactam 2.5g and aztreonam 2g every 8 hours, or a sequential infusion where ceftazidime-avibactam is given over 2 hours followed by aztreonam over 1 hour every 8 hours. The study is randomized and double-blinded, comparing the effects of these two dosing schedules. Both methods are being evaluated for their ability to reach effective drug levels and their impact on infection outcomes. During the trial, researchers will monitor patients for clinical cure rates within 14 days, microbiological eradication, and any adverse events. Assessments include genotypic testing to confirm bacterial resistance, clinical evaluations, and safety monitoring. The study will follow patients through their treatment period, with careful tracking of infection response and potential side effects to determine if one infusion method offers advantages over the other.
CONDITIONS
Brief Title
Different Administration Regimens of CAZ-AVI in Combination With ATM for the Treatment of CR-GNB
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with complicated intra-abdominal infection, hospital-acquired pneumonia, ventilator-associated pneumonia, complicated urinary tract infection, or bloodstream infection
- Confirmed infections caused by metallo-β-lactamase-producing carbapenem-resistant Gram-negative bacteria via genotypic testing
- Receiving treatment with ceftazidime-avibactam combined with aztreonam
- Age between 18 and 100 years
You will not qualify if you...
- Patients under 18 years old
- Known allergy or severe hypersensitivity to ceftazidime, avibactam, aztreonam, or related β-lactam antibiotics
- Pregnant or breastfeeding women
- Unable to understand or follow the study protocol
- Any condition deemed unsuitable for participation by the investigator
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 visit (in-person)
Duration - 14 days
Participants receive ceftazidime-avibactam combined with aztreonam through either concomitant or sequential intravenous infusion to treat infections caused by carbapenem-resistant Gram-negative bacteria.
Daily visits for treatment administration
Trial Site Locations
Total: 1 location
1
Jing Zhou
Nanjin, Jiangsu, China, 210000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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