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NCT07478484 | RECRUITING | Ceftazidime-avibactam

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

jinguizhou

Information provided by (Responsible Party):

jinguizhou

Brief Summary:

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 studies, significantly reducing infection-related mortality.However, although current domestic and international guidelines recommend the CZA+ATM combination for MBL infections, there is no consensus on optimal infusion strategies. Based on the above, this study hypothesizes that in patients with complicated infections caused by MBL-producing CR-GNB, different infusion modalities of ceftazidime-avibactam combined with aztreonam-concomitant infusion versus sequential infusion-will show no significant differences in PK/PD target attainment rates, clinical cure rates, microbiological eradication rates, or all-cause mortality, without increasing the risk of adverse events.

Condition or disease

Ceftazidime-avibactam

Aztreonam

Gram-negative Bacterial Infection

Metallo-β-lactamase-producing

Carbapenem-resistant

Intervention/treatment

ceftazidime-avibactam combined with aztreonam

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 144 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Clinical Study on Sequential Infusion Versus Concomitant Infusion of Ceftazidime-avibactam Combined With Aztreonam for the Treatment of Metallo-β-lactamase-producing Carbapenem-resistant Gram-negative Bacterial Infections.
Actual Study Start Date : 2026-03-31
Estimated Primary Completion Date : 2027-12-31
Estimated Study Completion Date : 2028-01-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Different Administration Regimens of CAZ-AVI in Combination With ATM for the Treatment of CR-GNB

Location Details

NCT07478484

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Locations

RECRUITING

China, Jiangsu

jinguizhou

NaN goes in, Jiangsu, China, 210000