About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Treating team deems enrolment in the study is not in the best interest of the patient
Patient is on end-of-life care
Patient is incarcerated in a correctional facility
Participation in any interventional study activities outlined in the TREAT-GNB study within the last 90 days
Trial design
Treatments tested in this trial
- Colistin/Polymyxin B + Sulbactam
- Colistin/Polymyxin B + Tigecycline/Eravacycline
- Colistin/Polymyxin B + Meropenem
- Ceftazidime-avibactam + Sulbactam
- Ceftazidime-avibactam + Fosfomycin
- Ceftazidime-avibactam
- Ceftazidime-avibactam + Aztreonam
- Ceftazidime-avibactam + Colistin/Polymyxin B
- High-dose meropenem
- Meropenem + Fosfomycin
- Meropenem-vaborbactam
- Cefiderocol
- Ceftolozane-tazobactam
- Ceftolozane-tazobactam + Meropenem
Treatment groups
14
Treatment groupsSee each treatment group below.
Sponsors and collaborators
National University of Singapore
Lead sponsor
The University of Queensland
Collaborator
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Collaborator