Optimising TREATment for Severe Gram-Negative Bacterial Infections

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational University of Singapore

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

600 Participants
are divided into 14 treatment groups

14

Treatment groups

See 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