Comparing Two Ways to Give Ceftazidime-avibactam and Aztreonam for Treating Infections Caused by Resistant Gram-negative Bacteria

What this Trial Is About

Metallo--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 -lactam antibiotics. Current inhibitors like avibactam cannot stop metallo--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.

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