TREAT-GNB is an innovative trial to expedite the evaluation of various antibiotic choices and treatment strategies for severe multidrug-resistant Gram-negative bacterial infections, specifically bloodstream and lower respiratory tract infections. This approach combines platform trial elements with adaptive clinical designs to streamline the evaluation of various treatment options and optimise resource utilisation. The overall aim of the TREAT-GNB platform trial is to identify interventions that improve survival in patients with severe infections due to Gram-negative bacteria.
In the CR-GNB silo of TREAT-GNB, the primary objective is to quantify the effect on all-cause mortality at 28 days of a range of interventions in patients with bloodstream infections, ventilator-associated pneumonia, and hospital-acquired pneumonia caused by CR-GNB.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Growth of Gram-negative bacilli identified from blood culture(s)
✓. Receiving or planning to receive intravenous antibiotics
✓. Expected time from blood culture sampling to randomisation is ≤ 96 hours.
✓. temperature \> 38 °C
✓. white blood cell count ≥ 12,000 cells/mm3 (12 x 109/L, 12 x 103/µL) or ≤ 4,000 cells/mm3 (4 x 109/L, 4 x 103/µL)
✓. altered mental status with no other causes in \> 70 years old; AND ii) Two or more chest imaging tests demonstrating at least one of the following:
✓. new onset of purulent sputum, or change in character of sputum, or increased respiratory secretions, or increased in suctioning requirements
✓. new onset or worsening tachypnoea or dyspnoea
Exclusion criteria
✕. Treating team deems enrolment in the study is not in the best interest of the patient