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New treatment option for Bloodstream Infection
Official title Optimising TREATment for Severe Gram-Negative Bacterial Infections
ClinicalTrials.gov ID: NCT07004049
What this study is testing
What is Colistin/Polymyxin B + Sulbactam?
Colistin/Polymyxin B + Sulbactam is an investigational medicine, being studied as a potential treatment for bloodstream infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- A: Bloodstream infections a) Suitable for at least 2 antibiotic regimens in the site randomisation list
- 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 ≤ 96 hours. OR B: Ventilator-associated pneumonia / hospital-acquired pneumonia a)...
- temperature \> 38 °C
You likely can't join if
- Treating team deems enrolment in the study is not in the best interest of the patient
- Patient is on end-of-life care
- Patient is incarcerated in a correctional facility
- Participation in any treatment study activities outlined in the TREAT-GNB study within the last 90 days
- Pregnant women and children OR
- Polymicrobial bloodstream infection
See the full eligibility criteria
- A: Bloodstream infections a) Suitable for at least 2 antibiotic regimens in the site randomisation list
- 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 ≤ 96 hours. OR B: Ventilator-associated pneumonia / hospital-acquired pneumonia a) Suitable for at least 2 antibiotic regimens in the site randomisation list...
- temperature \> 38 °C
- 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)
- 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...
- new onset of purulent sputum, or change in character of sputum, or increased respiratory secretions, or increased in suctioning requirements
- new onset or worsening tachypnoea or dyspnoea
- rales or bronchial breath sounds
- worsening gas exchange defined by oxygen desaturations (e.g., PaO2/FiO2 \ 48 hours d) Predominant growth of Gram-negative bacilli identified from respiratory tract specimen(s)\ ; e) Receiving or planning to receive...
- Treating team deems enrolment in the study is not in the best interest of the patient
- Patient is on end-of-life care
- Patient is incarcerated in a correctional facility
- Participation in any treatment study activities outlined in the TREAT-GNB study within the last 90 days
- Pregnant women and children OR
- Polymicrobial bloodstream infection
The study team makes the final eligibility decision.
Where it's taking place
- Brisbane, Queensland, Australia
- Brisbane, Australia
- Hangzhou, China
- Xi'an, China
- Xuzhou, China
- Beirut, Lebanon
- Kota Kinabalu, Sabah, Malaysia
- Miri, Sarawak, Malaysia
- Ampang, Selangor, Malaysia
- Sungai Buloh, Selangor, Malaysia
- Doha, Qatar
- Riyadh, Saudi Arabia
- Singapore, Singapore, Singapore
- Johannesburg, South Africa
- Alicante, Spain
- Badajoz, Spain
- Barakaldo, Spain
- Barcelona, Spain
- Córdoba, Spain
- Granada, Spain
+ 11 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brisbane, Queensland, Australia; Brisbane, Australia; Hangzhou, China; Xi'an, China; Xuzhou, China; Beirut, Lebanon and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.