Optimising TREATment for Severe Gram-Negative Bacterial Infections

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

TREAT-GNB [CR-GNB]

ClinicalTrials.gov ID

NCT07004049

Acronym / sponsor ID

TREAT-GNB / ADVANCE-ID 24003

Conditions

Bloodstream Infection, Ventilator Associated Bacterial Pneumonia, Hospital Acquired Bacterial Pneumonia, Carbapenem Resistant Bacterial Infection, Multidrug Resistance

Phase

Phase 4

Study type

Interventional

Recruitment status

Recruiting

Enrolment

600 participants (estimated)

Lead sponsor

National University of SingaporeUniversity, hospital or other

Collaborators

The University of Queensland, European Clinical Research Alliance for Infectious Diseases (ECRAID)

Study start

21 Apr 2025 (actual)

Primary completion

31 Dec 2028 (estimated)

Study completion

31 Dec 2028 (estimated)

First posted

4 Jun 2025 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Factorial

Masking

None (open label)

Number of arms

14

Model description

The backbone domain is a multi-arm antibiotic treatment intervention with a personalisable randomisation list. It adopts the "Personalised Randomised Controlled Trial" (PRACTical) design, which allows each participant to be randomised between a personalised randomisation list of treatments that are suitable for them. Each patient randomisation list ("personalised randomisation list") may be tailored based on their kidney function, pathogen genotype, pathogen antibiotic susceptibility and physician preference. Potential participants may be enrolled and randomised if they are eligible for at least two antibiotic options in the site randomisation list.

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Clinical outcome

   Time frame: 28 days post-randomisation

   28-day all-cause mortality after randomisation

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
• Background: PubMed 31866328Niederman MS, Alder J, Bassetti M, Boateng F, Cao B, Corkery K, Dhand R, Kaye KS, Lawatscheck R, McLeroth P, Nicolau DP, Wang C, Wood GC, Wunderink RG, Chastre J. Inhaled amikacin adjunctive to intravenous standard-of-care antibiotics in mechanically ventilated patients with Gram-negative pneumonia (INHALE): a double-blind, randomised, placebo-controlled, phase 3, superiority trial. Lancet Infect Dis. 2020 Mar;20(3):330-340. doi: 10.1016/S1473-3099(19)30574-2. Epub 2019 Dec 19.
• Background: PubMed 30535100Yahav D, Franceschini E, Koppel F, Turjeman A, Babich T, Bitterman R, Neuberger A, Ghanem-Zoubi N, Santoro A, Eliakim-Raz N, Pertzov B, Steinmetz T, Stern A, Dickstein Y, Maroun E, Zayyad H, Bishara J, Alon D, Edel Y, Goldberg E, Venturelli C, Mussini C, Leibovici L, Paul M; Bacteremia Duration Study Group. Seven Versus 14 Days of Antibiotic Therapy for Uncomplicated Gram-negative Bacteremia: A Noninferiority Randomized Controlled Trial. Clin Infect Dis. 2019 Sep 13;69(7):1091-1098. doi: 10.1093/cid/ciy1054.
• Background: PubMed 31654791McNamara JF, Harris PNA, Chatfield MD, Lorenc P, Paterson DL. Measuring patient-centred long-term outcome following a bloodstream infection: a pilot study. Clin Microbiol Infect. 2020 Feb;26(2):257.e1-257.e4. doi: 10.1016/j.cmi.2019.10.011. Epub 2019 Oct 23.
• Background: PubMed 26113652Evans SR, Rubin D, Follmann D, Pennello G, Huskins WC, Powers JH, Schoenfeld D, Chuang-Stein C, Cosgrove SE, Fowler VG Jr, Lautenbach E, Chambers HF. Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR). Clin Infect Dis. 2015 Sep 1;61(5):800-6. doi: 10.1093/cid/civ495. Epub 2015 Jun 25.
• Background: PubMed 33894130Walker AS, White IR, Turner RM, Hsu LY, Yeo TW, White NJ, Sharland M, Thwaites GE. Personalised randomised controlled trial designs-a new paradigm to define optimal treatments for carbapenem-resistant infections. Lancet Infect Dis. 2021 Jun;21(6):e175-e181. doi: 10.1016/S1473-3099(20)30791-X. Epub 2021 Apr 21.
• Individual participant dataSharing planned: Yes. De-identified patient data

Related trials for Bloodstream Infection

• Not yet recruitingObservational study

  Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care

  Sepsis, Circulatory Instability

• Not yet recruiting

  ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers

  Acute Respiratory Failure, Critical Illness

• RecruitingPhase 3

  THE ROLE OF PANCREATIC STONE PROTEIN (PSP) AND PSP-GUIDED EARLY MEROPENEM TREATMENT TO MITIGATE SEPSIS RISK AT THE EMERGENCY DEPARTMENT: THE PROMISE DOUBLE BLIND, PHASE III, RANDOMIZED CONTROLLED CLINICAL TRIAL

  Sepsis

• Not yet recruiting

  Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers

  Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia

• Not yet recruitingObservational study

  Longitudinal Trajectories of Myocardial Work in Patients With Sepsis

  Sepsis, Septic Shock Hyperdynamic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

41 sites in 12 countries: see every site and its status.