Optimising TREATment for Severe Gram-Negative Bacterial Infections

Summary

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.

Conditions

• Bloodstream Infection
• Ventilator Associated Bacterial Pneumonia
• Hospital Acquired Bacterial Pneumonia
• Carbapenem Resistant Bacterial Infection
• Multidrug Resistance

Interventions

DRUG

Colistin/Polymyxin B + Sulbactam

For carbapenem-resistant Acinetobacter infections in China, Malaysia, Thailand and Singapore

DRUG

Colistin/Polymyxin B + Tigecycline/Eravacycline

For carbapenem-resistant Acintobacter, carbapenem-resistant Enterobacterales infections in China, Malaysia, Thailand and Singapore

DRUG

Colistin/Polymyxin B + Meropenem

For carbapenem-resistant Pseudomonas aeruginosa, carbapenem-resistant Enterobacterales infections in China, Malaysia and Singapore

DRUG

Ceftazidime-avibactam + Sulbactam

For carbapenem-resistant Acinetobacter infections in China, Malaysia, Thailand, Singapore and Australia.

DRUG

Ceftazidime-avibactam + Fosfomycin

For carbapenem-resistant Pseudomonas aeruginosa, carbapenem-resistant Enterobacterales infections in Malaysia, Thailand and Singapore

DRUG

Ceftazidime-avibactam

For carbapenem-resistant Pseudomonas aeruginosa, carbapenem-resistant Enterobacterales infections in China, Malaysia, Thailand, Singapore, Europe and Australia.

DRUG

Ceftazidime-avibactam + Aztreonam

For carbapenem-resistant Enterobacterales infections in China, Malaysia, Thailand, Singapore, Europe and Australia.

DRUG

Ceftazidime-avibactam + Colistin/Polymyxin B

For carbapenem-resistant Pseudomonas aeruginosa in China, Malaysia, Thailand, Singapore and Europe.

DRUG

High-dose meropenem

For carbapenem-resistant Enterobacterales infection in Europe

DRUG

Meropenem + Fosfomycin

For carbapenem-resistant Enterobacterales in Europe

DRUG

Meropenem-vaborbactam

For carbapenem-resistant Enterobacterales infection in Europe

DRUG

Cefiderocol

For carbapenem-resistant Pseudomonas aeruginosa, carbapenem-resistant Enterobacterales infections in Europe and Australia.

DRUG

Ceftolozane-tazobactam

For carbapenem-resistant Pseudomonas aeruginosa in Europe and Australia.

DRUG

Ceftolozane-tazobactam + Meropenem

For carbapenem-resistant Pseudomonas aeruginosa in Europe.

Sponsors & Collaborators

• The University of Queensland

  collaborator OTHER

• European Clinical Research Alliance for Infectious Diseases (ECRAID)

  collaborator OTHER

• National University of Singapore

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-21

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• Australia
• China
• Lebanon
• Malaysia
• Qatar
• Saudi Arabia
• Singapore
• South Africa
• Spain
• Thailand
• Turkey (Türkiye)
• United Arab Emirates

Study Locations