Actively Recruiting
Optimising TREATment for Severe Gram-Negative Bacterial Infections
Led by National University of Singapore · Updated on 2025-06-04
600
Participants Needed
41
Research Sites
192 weeks
Total Duration
On this page
Sponsors
N
National University of Singapore
Lead Sponsor
T
The University of Queensland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Optimising TREATment for Severe Gram-Negative Bacterial Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 6 96 hours
- Suitable for at least 2 antibiotic regimens in the site randomisation list for bloodstream infections
- For ventilator-associated or hospital-acquired pneumonia: must be suitable for at least 2 antibiotic regimens in the site list
- Infection meets CDC National Healthcare Safety Network criteria, including fever, abnormal white blood cell count, altered mental status in those >70 years old
- Two or more chest imaging tests with new or progressive infiltrate, consolidation, or cavitation
- At least two signs including new purulent sputum, worsening breathing, abnormal lung sounds, or worsening gas exchange
- Hospital admission longer than 48 hours
- Predominant growth of Gram-negative bacilli from respiratory samples
- Expected time from respiratory culture sampling to randomisation is 6 96 hours
- Carbapenem-resistant Gram-negative bacilli (Acinetobacter baumannii-calcoaceticus complex, Pseudomonas aeruginosa, or Enterobacterales)
- Carbapenem resistance confirmed by microbiology testing or gene detection
You will not qualify if you...
- Treating team considers enrolment not in patient's best interest
- Patient is receiving end-of-life care
- Patient is incarcerated in a correctional facility
- Participation in any TREAT-GNB interventional study activities within last 90 days
- Pregnant women and children
- Polymicrobial bloodstream infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 41 locations
1
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4006
Not Yet Recruiting
2
Princess Alexandra Hospital
Brisbane, Australia
Not Yet Recruiting
3
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China, 310058
Not Yet Recruiting
4
The Second Affiliated Hospital, Xi'an Jiang Tong University
Xi'an, China, 710006
Not Yet Recruiting
5
Xuzhou First People's Hospital
Xuzhou, China, 221002
Not Yet Recruiting
6
American University of Beirut Medical Center
Beirut, Lebanon
Not Yet Recruiting
7
Queen Elizabeth I
Kota Kinabalu, Sabah, Malaysia, 88200
Not Yet Recruiting
8
Queen Elizabeth II
Kota Kinabalu, Sabah, Malaysia, 88300
Not Yet Recruiting
9
Miri Sarawak Hospital
Miri, Sarawak, Malaysia, 98000
Not Yet Recruiting
10
Ampang Hospital
Ampang, Selangor, Malaysia, 68000
Not Yet Recruiting
11
Hospital Sungai Buloh
Sungai Buloh, Selangor, Malaysia, 47000
Not Yet Recruiting
12
Hamad Medical Corporation
Doha, Qatar
Not Yet Recruiting
13
King Saud bin Abdulaziz University for Health Sciences
Riyadh, Saudi Arabia
Not Yet Recruiting
14
National University Hospital
Singapore, Singapore, Singapore, 119074
Actively Recruiting
15
Helen Joseph Hospital
Johannesburg, South Africa
Not Yet Recruiting
16
Hospital General Universitario Dr. Balmis
Alicante, Spain
Not Yet Recruiting
17
Hospital Universitario de Badajoz
Badajoz, Spain
Not Yet Recruiting
18
Hospital Universitario de Cruces
Barakaldo, Spain
Not Yet Recruiting
19
Hospital del Mar Barcelona
Barcelona, Spain, 08003
Not Yet Recruiting
20
Hospital Universitario Bellvitge
Barcelona, Spain
Not Yet Recruiting
21
Hospital Universitario Reina Sofía Córdoba
Córdoba, Spain
Not Yet Recruiting
22
Hospital Universitario San Cecilio
Granada, Spain
Not Yet Recruiting
23
Hospital Universitario Virgen de las Nieves
Granada, Spain
Not Yet Recruiting
24
Hospital Clínico San Carlos
Madrid, Spain
Not Yet Recruiting
25
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Not Yet Recruiting
26
Hospital Universitario de La Princesa
Madrid, Spain
Not Yet Recruiting
27
Hospital Universitario La Paz
Madrid, Spain
Not Yet Recruiting
28
Hospital Regional Universitario de Málaga
Málaga, Spain
Not Yet Recruiting
29
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Not Yet Recruiting
30
Hospital Álvaro Cunqueiro
Pontevedra, Spain
Not Yet Recruiting
31
Hospital Universitario de Donostia
San Sebastián, Spain
Not Yet Recruiting
32
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Not Yet Recruiting
33
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Not Yet Recruiting
34
Hospital Universitario Virgen de Valme
Seville, Spain
Not Yet Recruiting
35
Hospital Universitario Virgen del Rocío
Seville, Spain
Not Yet Recruiting
36
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Not Yet Recruiting
37
Phramongkutkloa Hospital
Bangkok, Thailand, 10400
Not Yet Recruiting
38
Rajavithi Hospital
Bangkok, Thailand, 10400
Not Yet Recruiting
39
Maharaj Nakorn Chiang Mai Hospital, Chiangmai University
Chiang Mai, Thailand, 50200
Not Yet Recruiting
40
İstanbul Medipol Üniversitesi
Istanbul, Turkey (Türkiye)
Not Yet Recruiting
41
Dubai Hospital
Dubai, United Arab Emirates
Not Yet Recruiting
Research Team
Y
Yin Mo, MBBS, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
14
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