RecruitingPhase 4NCT07004049

Optimising TREATment for Severe Gram-Negative Bacterial Infections

TREAT-GNB [CR-GNB]


Sponsor

National University of Singapore

Enrollment

600 participants

Start Date

Apr 21, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cefiderocol, a drug called Ceftazidime-avibactam, and others for people with carbapenem resistant bacterial infection, hospital-acquired bacterial pneumonia, and other related conditions. The study is currently recruiting participants at 41 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGColistin/Polymyxin B + Sulbactam

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

DRUGColistin/Polymyxin B + Tigecycline/Eravacycline

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

DRUGColistin/Polymyxin B + Meropenem

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

DRUGCeftazidime-avibactam + Sulbactam

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

DRUGCeftazidime-avibactam + Fosfomycin

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

DRUGCeftazidime-avibactam

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

DRUGCeftazidime-avibactam + Aztreonam

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

DRUGCeftazidime-avibactam + Colistin/Polymyxin B

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

DRUGHigh-dose meropenem

For carbapenem-resistant Enterobacterales infection in Europe

DRUGMeropenem + Fosfomycin

For carbapenem-resistant Enterobacterales in Europe

DRUGMeropenem-vaborbactam

For carbapenem-resistant Enterobacterales infection in Europe

DRUGCefiderocol

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

DRUGCeftolozane-tazobactam

For carbapenem-resistant Pseudomonas aeruginosa in Europe and Australia.

DRUGCeftolozane-tazobactam + Meropenem

For carbapenem-resistant Pseudomonas aeruginosa in Europe.


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

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

Hospital Universitario Reina Sofía Córdoba

Córdoba, Spain

Hospital Universitario San Cecilio

Granada, Spain

Hospital Universitario Virgen de las Nieves

Granada, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital Universitario de La Princesa

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Regional Universitario de Málaga

Málaga, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Álvaro Cunqueiro

Pontevedra, Spain

Hospital Universitario de Donostia

San Sebastián, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitario Virgen de Valme

Seville, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Phramongkutkloa Hospital

Bangkok, Thailand

Rajavithi Hospital

Bangkok, Thailand

Maharaj Nakorn Chiang Mai Hospital, Chiangmai University

Chiang Mai, Thailand

İstanbul Medipol Üniversitesi

Istanbul, Turkey (Türkiye)

Dubai Hospital

Dubai, United Arab Emirates

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07004049


Related Trials