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Massive trial aims to outsmart superbugs in blood infections

NCT ID NCT06537609

Disease control Sponsor: Sunnybrook Health Sciences Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study compares different antibiotic strategies for people hospitalized with Gram-negative bloodstream infections. The goal is to find which approach leads to better outcomes, like survival and fewer complications, while also reducing the risk of antibiotic resistance. About 2,500 participants will be enrolled across multiple hospitals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

PLATFORM INCLUSION CRITERIA Platform Inclusion Criteria: * admitted to a participating hospital * positive blood culture with Gram negative (GN) bacterium Platform Exclusion Criteria: * patient's goals of care are for palliation with no active treatment * moribund patient, not expected to survive \> 72 hours * previously enrolled in the platform trial * not eligible for any domain at the time of screening DOMAIN SPECIFIC INCLUSION AND EXCLUSION CRITERIA 1. De-escalation versus no de-escalation domain Inclusion Criteria \- included in BALANCE+ platform Exclusion Criteria * receiving an empiric antibiotic regimen at the time of blood culture finalization to which the GN pathogen(s) are not sensitive * arbapenem-non-susceptible * no de-escalation option due to any or all of: * antimicrobial resistance * allergies * medical contraindications * drug-drug interaction risk * other relevant reason * patients with a suspected or proven polymicrobial source of infection * \> 24 hours since index blood culture susceptibility results finalization 2. Beta-lactam versus non-beta-lactam oral/enteral treatment domain Inclusion Criteria * included in BALANCE+ platform * initially treated with intravenous antibiotics, but clinical team transitioning patient to oral/enteral antibiotic within 7 days of starting treatment Exclusion Criteria * enrolled in an arm of another BALANCE+ platform domain which limits the use of oral/enteral therapy: * no-de-escalation arm (patients in the no de-escalation arm cannot be randomized into this domain unless they are ready for discharge home, in which case de-escalation is allowable to oral agents at discharge) * no non-beta-lactam options due to any or all of: * resistance * allergies * medical contraindications * drug-interaction risk * other relevant reason * no beta-lactam options due to any or all of: * resistance * allergies * medical contraindications * drug-interaction risk * other relevant reason * pregnancy * already received \>24 hours of oral antibiotics after index blood culture finalization 3. Central vascular catheter replacement domain Inclusion Criteria * included in BALANCE+ platform * has an indwelling central vascular catheter that was already in place within the 48-hour period before the onset of bloodstream infection (i.e. is not a new catheter placed within 48 hours of the onset of infection) Exclusion Criteria * patient has no ongoing need for a central vascular catheter * patient has definite indication for central vascular catheter removal * ongoing septic shock with definite/probable line source * concomitant S. aureus bacteremia * concomitant candidemia * local suppurative signs (severe redness, warmth, pain, swelling or fluctuance/collection) necessitating catheter removal, or other clinical evidence of infected line (e.g. imaging/echocardiographic findings) 4. Low-risk AmpC domain Inclusion Criteria * included in BALANCE+ platform * positive blood culture with GN bacterium, of the following species: i. Serratia spp. ii Morganella spp. iii Providencia spp. iv Proteus spp. other than P.mirabilis * organism is susceptible to ceftriaxone Exclusion Criteria * severe allergy to beta-lactams (e.g., type 4 hypersensitivity reaction or DRESS) * baseline phenotypic non-susceptiblity to ceftriaxone * more than 1 calendar day beyond availability of susceptibility results 5. Follow up blood culture domain Inclusion Criteria \- included in BALANCE+ platform Exclusion Criteria * patient died or discharged from hospital prior to day 4 * blood culture already collected by the treating team at day 4±1 * \>5 days since index positive blood culture collection * definite indication for repeat blood culture testing * concomitant S. aureus bacteremia * concomitant Candidemia * clinical suspicion for infective endocarditis

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Conditions

The condition(s) this trial relates to.

gram-negative bacterial infections

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gram-negative bacteremia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    39 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU de Québec - Université Laval

    RECRUITING

    Laval, Quebec, Canada

  • Centre hospitalier affilié universitaire régional (CHAUR)

    RECRUITING

    Trois-Rivières, Quebec, G8Z 3R9, Canada

  • Dr. Everett Chalmers Regional Hospital

    RECRUITING

    Fredericton, New Brunswick, Canada

  • Eastern Regional Health Authority

    RECRUITING

    St. John's, Newfoundland and Labrador, Canada

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, Western Australia, Australia

  • Foothills Hospital

    RECRUITING

    Calgary, Alberta, Canada

  • Grace Hospital

    RECRUITING

    Winnipeg, Manitoba, Canada

  • Health Sciences Centre

    RECRUITING

    Winnipeg, Manitoba, Canada

  • Humber River Health system

    RECRUITING

    North York, Ontario, Canada

  • Hôpital de la Cité de la Santé

    RECRUITING

    Laval, Quebec, Canada

  • John Hunter Hospital

    RECRUITING

    New Lambton, New South Wales, Australia

  • Michael Garron Hospital

    RECRUITING

    Toronto, Ontario, Canada

  • Middlemore Hospital

    RECRUITING

    Auckland, Auckland, 2025, New Zealand

  • Monash Medical Center

    RECRUITING

    Clayton, Victoria, Australia

  • Montreal General Hospital- McGill

    RECRUITING

    Montreal, Quebec, Canada

  • Mount Sinai Hospital

    RECRUITING

    Toronto, Ontario, Canada

  • Niagara Health System

    RECRUITING

    St. Catharines, Ontario, Canada

  • North York General Hospital

    RECRUITING

    North York, Ontario, Canada

  • Peter Lougheed Centre

    RECRUITING

    Calgary, Alberta, Canada

  • Redcliffe Hospital

    RECRUITING

    Redcliffe, Queensland, Australia

  • Rockyview General Hospital

    RECRUITING

    Calgary, Alberta, Canada

  • Royal Brisbane and Women's Hospital

    RECRUITING

    Herston, Queensland, 4006, Australia

  • Royal Victoria Hospital- McGill

    RECRUITING

    Montreal, Quebec, Canada

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, Tel Aviv, Israel

  • South Health Campus

    RECRUITING

    Calgary, Alberta, Canada

  • St George Hospital

    RECRUITING

    Kogarah, New South Wales, 2217, Australia

  • St John of God

    RECRUITING

    Murdoch, Western Australia, Australia

  • St. Boniface Hospital

    RECRUITING

    Winnipeg, Manitoba, Canada

  • St. Joseph's Health Centre

    RECRUITING

    Toronto, Ontario, Canada

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, M4N3M5, Canada

  • Sunshine Coast University Hospital

    RECRUITING

    Sunshine Coast, Queensland, Australia

  • Surrey Memorial Hospital

    RECRUITING

    Surrey, British Columbia, Canada

  • The Ottawa Hospital

    RECRUITING

    Ottawa, Ontario, Canada

  • Trillium Health Partners - Mississauga Hospital

    RECRUITING

    Mississauga, Ontario, Canada

  • Universidad de La Sabana

    RECRUITING

    Chía, Cundinamarca, Colombia

  • University Health Network

    RECRUITING

    Toronto, Ontario, Canada

  • University of Alberta

    RECRUITING

    Edmonton, Alberta, Canada

  • Université de Sherbrooke

    RECRUITING

    Sherbrooke, Quebec, Canada

  • Vancouver General Hospital

    RECRUITING

    Vancouver, British Columbia, Canada

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