A Platform Trial for Gram Negative Bloodstream Infections
ConditionGram-negative Bacteremia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-130
SponsorSunnybrook Health Sciences Centre
About this trial
BALANCE+ is a perpetual multiple domain randomized controlled platform trial to evaluate various treatment strategies for Gram-negative bloodstream infections (GN BSIs). Each domain addresses critical questions in the management of GN BSIs, aiming to refine treatment strategies, enhance patient outcomes, and reduce antimicrobial resistance.
The initial vanguard pilot RCT (NCT05893147) started on 29 August 2023 and has successfully completed the pilot phase on 24-Apr-2024. All patients enrolled in the vanguard phase are part of the main platform trial.
Eligibility criteria
Qualifiers
admitted to a participating hospital
positive blood culture with Gram negative (GN) bacterium
Disqualifiers
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
Trial design
Treatments tested in this trial
- De-escalation VS No De-escalation
- Oral beta-lactams VS non beta-lactams
- Central vascular catheter retention VS Central vascular catheter replacement
- Cephalosporin VS Carbapenem for low risk AmpC organisms
- Routine follow-up blood culture VS No routine follow-up blood culture
Treatment groups
2,500 Participants
are divided into 5 treatment groupsSponsors and collaborators
Sunnybrook Health Sciences Centre
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Clínica Universidad de La Sabana
Collaborator
Universidad de La Sabana, Colombia
Collaborator
Aotearoa Clinical Trials
Collaborator
Source ClinicalTrials.gov