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Optimising TREATment for Severe Gram-Negative Bacterial Infections

ConditionsBloodstream InfectionVentilator Associated Bacterial PneumoniaHospital Acquired Bacterial PneumoniaCarbapenem Resistant Bacterial InfectionMultidrug Resistance
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational University of Singapore

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

temperature > 38 °C

Disqualifiers

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 interventional study activities outlined in the TREAT-GNB study within the last 90 days

Trial design

Design model

Factorial

Treatments tested in this trial

  • Colistin/Polymyxin B + Sulbactam

    Drug

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

  • Colistin/Polymyxin B + Tigecycline/Eravacycline

    Drug

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

  • Colistin/Polymyxin B + Meropenem

    Drug

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

  • Ceftazidime-avibactam + Sulbactam

    Drug

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

  • Ceftazidime-avibactam + Fosfomycin

    Drug

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

  • Ceftazidime-avibactam

    Drug

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

  • Ceftazidime-avibactam + Aztreonam

    Drug

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

  • Ceftazidime-avibactam + Colistin/Polymyxin B

    Drug

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

  • High-dose meropenem

    Drug

    For carbapenem-resistant Enterobacterales infection in Europe

  • Meropenem + Fosfomycin

    Drug

    For carbapenem-resistant Enterobacterales in Europe

  • Meropenem-vaborbactam

    Drug

    For carbapenem-resistant Enterobacterales infection in Europe

  • Cefiderocol

    Drug

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

  • Ceftolozane-tazobactam

    Drug

    For carbapenem-resistant Pseudomonas aeruginosa in Europe and Australia.

  • Ceftolozane-tazobactam + Meropenem

    Drug

    For carbapenem-resistant Pseudomonas aeruginosa in Europe.

Treatment groups

600 Participants
are divided into 14 treatment groups

14

Treatment groups

See each treatment group below.

Group A: Colistin/Polymyxin B + SulbactamActive comparator 1 intervention
Group B: Colistin/Polymyxin B + Tigecycline/EravacyclineActive comparator 1 intervention
Group C: Colistin/Polymyxin B + MeropenemActive comparator 1 intervention
Group D: Ceftazidime-avibactam + SulbactamActive comparator 1 intervention
Group E: Ceftazidime-avibactam + FosfomycinActive comparator 1 intervention
Group F: Ceftazidime-avibactamActive comparator 1 intervention
Group G: Ceftazidime-avibactam + AztreonamActive comparator 1 intervention
Group H: Ceftazidime-avibactam + Colistin/Polymyxin BActive comparator 1 intervention
Group I: High-dose meropenemActive comparator 1 intervention
Group J: Meropenem + FosfomycinActive comparator 1 intervention
Group K: Meropenem-vaborbactamActive comparator 1 intervention
Group L: CefiderocolActive comparator 1 intervention
Group M: Ceftolozane-tazobactamActive comparator 1 intervention
Group N: Ceftolozane-tazobactam + MeropenemActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical outcome

28-day all-cause mortality after randomisation

Time frame
28 days post-randomisation

Secondary outcomes

1

Clinical outcome

All-cause mortality at 14, 60 and 90 days after randomisation

Time frame
14, 60 and 90 days post-randomisation
2

Clinical outcome

Proportion of patients with infection relapse or reinfection within 90 days after randomisation

Time frame
90 days post-randomisation
3

Clinical outcome

Length of mechanical ventilation in the intensive care within 28 days after randomisation

Time frame
28 days post-randomisation
4

Clinical outcome

All cause re-admission into an acute care hospital within 90 days after randomisation

Time frame
90 days post-randomisation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University of Singapore

Lead sponsor

The University of Queensland

Collaborator

European Clinical Research Alliance for Infectious Diseases (ECRAID)

Collaborator

Source ClinicalTrials.gov
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