TREAT-GNB Phase 4 Trial Evaluating Antibiotic Treatments for Severe Carbapenem-Resistant Gram-Negative Bacterial Infections in Bloodstream and Lung

What this Trial Is About

Researchers are evaluating various antibiotic treatments for severe multidrug-resistant Gram-negative bacterial infections, focusing on bloodstream infections, ventilator-associated pneumonia, and hospital-acquired pneumonia caused by carbapenem-resistant Gram-negative bacteria. This innovative platform trial uses adaptive clinical designs to speed up assessment and optimize resources, aiming to find interventions that improve survival in these serious infections. The study compares multiple antibiotic regimens, including combinations like ColistinPolymyxin B with Sulbactam or TigecyclineEravacycline, Ceftazidime-avibactam alone or combined with other drugs, high-dose meropenem, and others. These treatments are given intravenously to patients with confirmed infections caused by resistant bacteria, with random assignment to different treatment groups. The trial includes a primary phase evaluating outcomes at 28 days post-randomisation. Participants will be monitored closely with clinical assessments at multiple time points, including 14, 28, 60, and 90 days after randomisation. Researchers will track all-cause mortality and other clinical outcomes to evaluate the effectiveness of each treatment. Safety and health economics outcomes will also be recorded. The study is led by the National University of Singapore and plans to run until the end of 2028.

Optimising TREATment for Severe Gram-Negative Bacterial Infections