№ files_lp_4_process_2_61226
Randomized clinical trial protocol and supplementary data detailing study design, patient eligibility, ethical approvals, and treatment regimens for aztreonam-avibactam versus comparator therapy in adults with serious MBL-positive Gram-negative infections.
Year: 2026
Countries involved: China, Greece, India, Malaysia, Mexico, Philippines, Romania, Russian Federation, Thailand, Spain
Study type: Phase 3 randomized clinical trial
Therapeutic area: Infectious diseases, antibacterial therapy
Pathogens: Metallo-β-lactamase-producing Gram-negative bacteria
Interventions: Aztreonam-avibactam, comparator therapy (best available therapy)
Patient population: Adults ≥18 years with serious bacterial infections (cIAI, HAP, VAP, cUTI, BSI)
Enrollment period: Screening to day 45 follow-up
Ethics approval: Local IEC/IRB approvals in all participating countries
Primary endpoints: Clinical and microbiological outcomes at test-of-cure (day 28 ±3)
Secondary endpoints: Safety and tolerability during and after treatment
Authors: George L. Daikos, José Miguel Cisneros, Yehuda Carmeli, Minggui Wang, Chee Loon Leong, Konstantinos Pontikis, Anastasia Anderzhanova, Simin Florescu, Roman Kozlov, Eduardo Rodriguez-Noriega, Mina Psichogiou, Pinyo Rattanaumpawan, Anca Streinu-Cercel, Venkatasubramanian Ramasubramanian, Francis F. Arhin, Halley Rogers, Michele Wible, Joanne Leaney, Daria Jacobson, Rienk Pypstra, Joseph W. Chow
Price: 8 / 10 USD
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