Trials / Recruiting
RecruitingNCT07004049
Optimising TREATment for Severe Gram-Negative Bacterial Infections
TREAT-GNB [CR-GNB]
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- Sponsor
- National University of Singapore · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Bloodstream Infection
- Ventilator Associated Bacterial Pneumonia
- Hospital Acquired Bacterial Pneumonia
- Carbapenem Resistant Bacterial Infection
- Multidrug Resistance
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-04-21
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
- First posted
- 2025-06-04
- Last updated
- 2025-06-04
Locations
41 sites across 12 countries: Australia, China, Lebanon, Malaysia, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Thailand, Turkey (Türkiye), United Arab Emirates
Source: ClinicalTrials.gov record NCT07004049. Inclusion in this directory is not an endorsement.