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RECRUITINGPhase 4INTERVENTIONAL

Optimising TREATment for Severe Gram-Negative Bacterial Infections

TREAT-GNB [CR-GNB]

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: A: Bloodstream infections a) Suitable for at least 2 antibiotic regimens in the site randomisation list 1. Growth of Gram-negative bacilli identified from blood culture(s) 2. Receiving or planning to receive intravenous antibiotics 3. Expected time from blood culture sampling to randomisation is ≤ 96 hours. OR B: Ventilator-associated pneumonia / hospital-acquired pneumonia a) Suitable for at least 2 antibiotic regimens in the site randomisation list b) Infection syndrome definitions\^( (US Centers for Disease Control and Prevention National Healthcare Safety Network)3: i) At least one of the following: 1. temperature \> 38 °C 2. 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) 3. 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: 1\) new and progressive OR progressive and persistent infiltrate 2) new and persistent OR progressive and persistent consolidation 3) new and persistent OR progressive and persistent cavitation; AND iii) At least two of the following: 1. new onset of purulent sputum, or change in character of sputum, or increased respiratory secretions, or increased in suctioning requirements 2. new onset or worsening tachypnoea or dyspnoea 3. rales or bronchial breath sounds 4. worsening gas exchange defined by oxygen desaturations (e.g., PaO2/FiO2 \< 240), increased oxygen requirements or increased ventilation demand. c) Hospital admission \> 48 hours d) Predominant growth of Gram-negative bacilli identified from respiratory tract specimen(s)\*; e) Receiving or planning to receive intravenous antibiotics f) Expected time from respiratory culture sampling to randomisation is ≤ 96 hours AND C: CR-GNB antibiotic backbone domain ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: A: Bloodstream infections a) Suitable for at least 2 antibiotic regimens in the site randomisation list 1. Growth of Gram-negative bacilli identified from blood culture(s) 2. Receiving or planning to receive intravenous antibiotics 3. Expected time from blood culture sampling to randomisation is ≤ 96 hours. OR B: Ventilator-associated pneumonia / hospital-acquired pneumonia a) Suitable for at least 2 antibiotic regimens in the site randomisation list b) Infection syndrome definitions\^( (US Centers for Disease Control and Prevention National Healthcare Safety Network)3: i) At least one of the following: 1. temperature \> 38 °C 2. 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) 3. 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: 1\) new and progressive OR progressive and persistent infiltrate 2) new and persistent OR progressive and persistent consolidation 3) new and persistent OR progressive and persistent cavitation; AND iii) At least two of the following: 1. new onset of purulent sputum, or change in character of sputum, or increased respiratory secretions, or increased in suctioning requirements 2. new onset or worsening tachypnoea or dyspnoea 3. rales or bronchial breath sounds 4. worsening gas exchange defined by oxygen desaturations (e.g., PaO2/FiO2 \< 240), increased oxygen requirements or increased ventilation demand. c) Hospital admission \> 48 hours d) Predominant growth of Gram-negative bacilli identified from respiratory tract specimen(s)\*; e) Receiving or planning to receive intravenous antibiotics f) Expected time from respiratory culture sampling to randomisation is ≤ 96 hours AND C: CR-GNB antibiotic backbone domain a) Gram-negative bacilli belonging to Acinetobacter baumannii-calcoaceticus complex, Pseudomonas aeruginosa or Enterobacterales b) Carbapenem resistance in isolate detected - i) Phenotypically via conventional microbiology testing: meropenem / imipenem / ertapenem resistance; OR ii) Genotypically via PCR or next generation sequencing: presence of genes associated with carbapenemase production (eg. blaNDM, blaKPC, blaIMP, blaIMI, blaVIM, blaOXA-48-like). Exclusion Criteria: 1. Treating team deems enrolment in the study is not in the best interest of the patient 2. Patient is on end-of-life care 3. Patient is incarcerated in a correctional facility 4. Participation in any interventional study activities outlined in the TREAT-GNB study within the last 90 days 5. Pregnant women and children OR 6. Polymicrobial bloodstream infection

Treatments Being Tested

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.

Locations (20)

Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Australia
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
The Second Affiliated Hospital, Xi'an Jiang Tong University
Xi'an, China
Xuzhou First People's Hospital
Xuzhou, China
American University of Beirut Medical Center
Beirut, Lebanon
Queen Elizabeth I
Kota Kinabalu, Sabah, Malaysia
Queen Elizabeth II
Kota Kinabalu, Sabah, Malaysia
Miri Sarawak Hospital
Miri, Sarawak, Malaysia
Ampang Hospital
Ampang, Selangor, Malaysia
Hospital Sungai Buloh
Sungai Buloh, Selangor, Malaysia
Hamad Medical Corporation
Doha, Qatar
King Saud bin Abdulaziz University for Health Sciences
Riyadh, Saudi Arabia
National University Hospital
Singapore, Singapore, Singapore
Helen Joseph Hospital
Johannesburg, South Africa
Hospital General Universitario Dr. Balmis
Alicante, Spain
Hospital Universitario de Badajoz
Badajoz, Spain
Hospital Universitario de Cruces
Barakaldo, Spain
Hospital del Mar Barcelona
Barcelona, Spain
Hospital Universitario Bellvitge
Barcelona, Spain