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Optimising TREATment for Severe Gram-Negative Bacterial Infections | Clinical Trials | Clareo Health

RECRUITINGPHASE4

Optimising TREATment for Severe Gram-Negative Bacterial Infections

TREAT-GNB [CR-GNB]

NCT07004049•National University of Singapore

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
+9 more criteria

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

Locations (41)

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

Key Dates

Start Date

April 21, 2025

Primary Completion Date

December 31, 2028

Completion Date

December 31, 2028

Last Updated

June 4, 2025

Enrollment

600

ESTIMATED participants

Conditions

Bloodstream InfectionVentilator Associated Bacterial PneumoniaHospital Acquired Bacterial PneumoniaCarbapenem Resistant Bacterial InfectionMultidrug Resistance

Interventions

Colistin/Polymyxin B + Sulbactam

DRUG

Colistin/Polymyxin B + Tigecycline/Eravacycline

DRUG

Colistin/Polymyxin B + Meropenem

DRUG

Ceftazidime-avibactam + Sulbactam

DRUG

Ceftazidime-avibactam + Fosfomycin

DRUG

Ceftazidime-avibactam

DRUG

Ceftazidime-avibactam + Aztreonam

DRUG

Ceftazidime-avibactam + Colistin/Polymyxin B

DRUG

High-dose meropenem

DRUG

Meropenem + Fosfomycin

DRUG

Meropenem-vaborbactam

DRUG

Cefiderocol

DRUG

Ceftolozane-tazobactam

DRUG

Ceftolozane-tazobactam + Meropenem

DRUG

Contacts

Yin Mo, MBBS, PhD

CONTACT

+65 65164988 mdcmy@nus.edu.sg

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Optimising TREATment for Severe Gram-Negative Bacterial Infections

Inclusion Criteria

Exclusion Criteria

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