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Different Administration Regimens of CAZ-AVI in Combination With ATM for the Treatment of CR-GNB

RecruitingPhase 4Ages 18 Years - 100 YearsAllJing Zhou
NCT07478484 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Metallo-β-lactamase-producing carbapenem-resistant Gram-negative bacteria (MBL-CR-GNB), due to their capacity to hydrolyze almost all β-lactam antibiotics, have become a critical global threat in antimicrobial resistance. Current novel β-lactamase inhibitors (e.g., avibactam, relebactam, vaborbactam) only inhibit serine enzymes and are ineffective against metallo-β-lactamases (MBL), severely limiting clinical treatment options. Aztreonam (ATM) is inherently stable against MBL, while avibactam (AVI) inhibits co-produced serine β-lactamases (e.g., KPC, OXA-48). Their combination achieves complementary synergistic antibacterial effects. The ceftazidime-avibactam plus aztreonam (CZA+ATM) regimen, operating via the mechanism of "avibactam protecting aztreonam", has demonstrated synergistic bactericidal activity against NDM, VIM, IMP and other MBL-producers in multiple real-world and clinical

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients diagnosed with complicated intra-abdominal infection (cIAI), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), complicated urinary tract infection (cUTI), or bloodstream infection (BSI); 2. Patients with confirmed infections caused by metallo-β-lactamase-producing carbapenem-resistant Gram-negative bacteria (MBL-CR-GNB), as determined by genotypic testing using next-generation sequencing (NGS) or carbapenem resistance gene testing; 3. Patients receiving treatment with ceftazidime-avibactam in combination with aztreonam. Exclusion Criteria: 1. Patients aged under 18 years; 2. Patients with known hypersensitivity to ceftazidime, avibactam, aztreonam, or any of the excipients; or those with a history of severe hypersensitivity reactions (e.g., anaphylactic shock, severe skin reactions) to any other β-lactam antibacterial agents (such as penicillins, monobactams, or carbapenems); 3. Pregnant or breastfeeding women; 4. Patients unable to comprehend or comply with the study protocol; 5. Any other condition which, in the investigator's discretion, makes the patient unsuitable for participation in the trial.
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What it tests

  • ceftazidime-avibactam combined with aztreonam
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Where

1 site
Jing Zhou
Nanjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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