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

NCT07478484 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

  • Ceftazidime-avibactam
  • Aztreonam
  • Gram-negative Bacterial Infection
  • Metallo-β-lactamase-producing
  • Carbapenem-resistant

Interventions

DRUG

ceftazidime-avibactam combined with aztreonam

Ceftazidime-avibactam 2.5g every 8 hours (q8h) administered as a 3-hour concomitant intravenous infusion with aztreonam 2g q8h, versus ceftazidime-avibactam 2.5g q8h infused over 2 hours followed by a 1-hour intravenous infusion of aztreonam

Sponsors & Collaborators

  • Jing Zhou

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-12-31
Completion
2028-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07478484 on ClinicalTrials.gov