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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07004049




Registration number
NCT07004049
Ethics application status
Date submitted
29/04/2025
Date registered
4/06/2025
Date last updated
4/06/2025

Titles & IDs
Public title
Optimising TREATment for Severe Gram-Negative Bacterial Infections
Scientific title
TREAT-GNB [CR-GNB]
Secondary ID [1] 0 0
ADVANCE-ID 24003
Universal Trial Number (UTN)
Trial acronym
TREAT-GNB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bloodstream Infection 0 0
Ventilator Associated Bacterial Pneumonia 0 0
Hospital Acquired Bacterial Pneumonia 0 0
Carbapenem Resistant Bacterial Infection 0 0
Multidrug Resistance 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Colistin/Polymyxin B + Sulbactam
Treatment: Drugs - Colistin/Polymyxin B + Tigecycline/Eravacycline
Treatment: Drugs - Colistin/Polymyxin B + Meropenem
Treatment: Drugs - Ceftazidime-avibactam + Sulbactam
Treatment: Drugs - Ceftazidime-avibactam + Fosfomycin
Treatment: Drugs - Ceftazidime-avibactam
Treatment: Drugs - Ceftazidime-avibactam + Aztreonam
Treatment: Drugs - Ceftazidime-avibactam + Colistin/Polymyxin B
Treatment: Drugs - High-dose meropenem
Treatment: Drugs - Meropenem + Fosfomycin
Treatment: Drugs - Meropenem-vaborbactam
Treatment: Drugs - Cefiderocol
Treatment: Drugs - Ceftolozane-tazobactam
Treatment: Drugs - Ceftolozane-tazobactam + Meropenem

Active comparator: Colistin/Polymyxin B + Sulbactam -

Active comparator: Colistin/Polymyxin B + Tigecycline/Eravacycline -

Active comparator: Colistin/Polymyxin B + Meropenem -

Active comparator: Ceftazidime-avibactam + Sulbactam -

Active comparator: Ceftazidime-avibactam + Fosfomycin -

Active comparator: Ceftazidime-avibactam -

Active comparator: Ceftazidime-avibactam + Aztreonam -

Active comparator: Ceftazidime-avibactam + Colistin/Polymyxin B -

Active comparator: High-dose meropenem -

Active comparator: Meropenem + Fosfomycin -

Active comparator: Meropenem-vaborbactam -

Active comparator: Cefiderocol -

Active comparator: Ceftolozane-tazobactam -

Active comparator: Ceftolozane-tazobactam + Meropenem -


Treatment: Drugs: Colistin/Polymyxin B + Sulbactam
For carbapenem-resistant Acinetobacter infections in China, Malaysia, Thailand and Singapore

Treatment: Drugs: Colistin/Polymyxin B + Tigecycline/Eravacycline
For carbapenem-resistant Acintobacter, carbapenem-resistant Enterobacterales infections in China, Malaysia, Thailand and Singapore

Treatment: Drugs: Colistin/Polymyxin B + Meropenem
For carbapenem-resistant Pseudomonas aeruginosa, carbapenem-resistant Enterobacterales infections in China, Malaysia and Singapore

Treatment: Drugs: Ceftazidime-avibactam + Sulbactam
For carbapenem-resistant Acinetobacter infections in China, Malaysia, Thailand, Singapore and Australia.

Treatment: Drugs: Ceftazidime-avibactam + Fosfomycin
For carbapenem-resistant Pseudomonas aeruginosa, carbapenem-resistant Enterobacterales infections in Malaysia, Thailand and Singapore

Treatment: Drugs: Ceftazidime-avibactam
For carbapenem-resistant Pseudomonas aeruginosa, carbapenem-resistant Enterobacterales infections in China, Malaysia, Thailand, Singapore, Europe and Australia.

Treatment: Drugs: Ceftazidime-avibactam + Aztreonam
For carbapenem-resistant Enterobacterales infections in China, Malaysia, Thailand, Singapore, Europe and Australia.

Treatment: Drugs: Ceftazidime-avibactam + Colistin/Polymyxin B
For carbapenem-resistant Pseudomonas aeruginosa in China, Malaysia, Thailand, Singapore and Europe.

Treatment: Drugs: High-dose meropenem
For carbapenem-resistant Enterobacterales infection in Europe

Treatment: Drugs: Meropenem + Fosfomycin
For carbapenem-resistant Enterobacterales in Europe

Treatment: Drugs: Meropenem-vaborbactam
For carbapenem-resistant Enterobacterales infection in Europe

Treatment: Drugs: Cefiderocol
For carbapenem-resistant Pseudomonas aeruginosa, carbapenem-resistant Enterobacterales infections in Europe and Australia.

Treatment: Drugs: Ceftolozane-tazobactam
For carbapenem-resistant Pseudomonas aeruginosa in Europe and Australia.

Treatment: Drugs: Ceftolozane-tazobactam + Meropenem
For carbapenem-resistant Pseudomonas aeruginosa in Europe.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical outcome
Timepoint [1] 0 0
28 days post-randomisation
Secondary outcome [1] 0 0
Clinical outcome
Timepoint [1] 0 0
14, 60 and 90 days post-randomisation
Secondary outcome [2] 0 0
Clinical outcome
Timepoint [2] 0 0
90 days post-randomisation
Secondary outcome [3] 0 0
Clinical outcome
Timepoint [3] 0 0
28 days post-randomisation
Secondary outcome [4] 0 0
Clinical outcome
Timepoint [4] 0 0
90 days post-randomisation
Secondary outcome [5] 0 0
Clinical outcome
Timepoint [5] 0 0
28 days post-randomisation
Secondary outcome [6] 0 0
Clinical outcome
Timepoint [6] 0 0
28 days post-randomisation
Secondary outcome [7] 0 0
Clinical outcome
Timepoint [7] 0 0
28 and 90 days post-randomisation
Secondary outcome [8] 0 0
Clinical outcome
Timepoint [8] 0 0
28 days post-randomisation
Secondary outcome [9] 0 0
Clinical outcome
Timepoint [9] 0 0
14 days post-randomisation
Secondary outcome [10] 0 0
Clinical outcome
Timepoint [10] 0 0
14 days post-randomisation
Secondary outcome [11] 0 0
Clinical outcome
Timepoint [11] 0 0
14, 28 and 90 days post-randomisation
Secondary outcome [12] 0 0
Health economics outcomes
Timepoint [12] 0 0
28 days post-randomisation
Secondary outcome [13] 0 0
Health economics outcomes
Timepoint [13] 0 0
28 days post-randomisation
Secondary outcome [14] 0 0
Health economics outcomes
Timepoint [14] 0 0
28 days post-randomisation
Secondary outcome [15] 0 0
Health economics outcomes
Timepoint [15] 0 0
28 and 90 days post-randomisation

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Hangzhou
Country [2] 0 0
China
State/province [2] 0 0
Xi'an
Country [3] 0 0
China
State/province [3] 0 0
Xuzhou
Country [4] 0 0
Lebanon
State/province [4] 0 0
Beirut
Country [5] 0 0
Malaysia
State/province [5] 0 0
Sabah
Country [6] 0 0
Malaysia
State/province [6] 0 0
Sarawak
Country [7] 0 0
Malaysia
State/province [7] 0 0
Selangor
Country [8] 0 0
Qatar
State/province [8] 0 0
Doha
Country [9] 0 0
Saudi Arabia
State/province [9] 0 0
Riyadh
Country [10] 0 0
Singapore
State/province [10] 0 0
Singapore
Country [11] 0 0
South Africa
State/province [11] 0 0
Johannesburg
Country [12] 0 0
Spain
State/province [12] 0 0
Alicante
Country [13] 0 0
Spain
State/province [13] 0 0
Badajoz
Country [14] 0 0
Spain
State/province [14] 0 0
Barakaldo
Country [15] 0 0
Spain
State/province [15] 0 0
Barcelona
Country [16] 0 0
Spain
State/province [16] 0 0
Córdoba
Country [17] 0 0
Spain
State/province [17] 0 0
Granada
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid
Country [19] 0 0
Spain
State/province [19] 0 0
Málaga
Country [20] 0 0
Spain
State/province [20] 0 0
Pontevedra
Country [21] 0 0
Spain
State/province [21] 0 0
San Sebastián
Country [22] 0 0
Spain
State/province [22] 0 0
Santander
Country [23] 0 0
Spain
State/province [23] 0 0
Seville
Country [24] 0 0
Spain
State/province [24] 0 0
Zaragoza
Country [25] 0 0
Thailand
State/province [25] 0 0
Bangkok
Country [26] 0 0
Thailand
State/province [26] 0 0
Chiang Mai
Country [27] 0 0
Turkey
State/province [27] 0 0
Istanbul
Country [28] 0 0
United Arab Emirates
State/province [28] 0 0
Dubai

Funding & Sponsors
Primary sponsor type
Other
Name
National University of Singapore
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Queensland
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Yin Mo, MBBS, PhD
Address 0 0
Country 0 0
Phone 0 0
+65 65164988
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07004049