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Antibiotic

Treatment Strategies for Bacterial Blood Infections

N/A
Recruiting
Led By Nick Daneman, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Organism is susceptible to ceftriaxone
Must not have
Receiving an empiric antibiotic regimen at the time of blood culture finalization to which the GN pathogen(s) are not sensitive
Arbapenem-non-susceptible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Summary

This trial, called BALANCE+, is testing different treatment strategies for Gram-negative bloodstream infections. It is divided into multiple parts, each focusing on important aspects of managing these infections to improve patient outcomes and reduce

Who is the study for?
This trial is for patients with Gram-negative bloodstream infections, which can lead to conditions like sepsis. Participants must meet certain health standards not specified here. People who don't fit the study's specific medical criteria cannot join.
What is being tested?
The BALANCE+ trial tests different treatments for bacterial blood infections: routine vs no follow-up blood culture, de-escalation of treatment or not, oral beta-lactams vs other drugs, and strategies for managing central vascular catheters.
What are the potential side effects?
Potential side effects are not detailed but may include reactions to antibiotics such as digestive issues, allergic reactions, and possibly increased antimicrobial resistance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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The infection I have responds to ceftriaxone treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on antibiotics that don't work against my infection.
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My infection is resistant to certain antibiotics.
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I have an infection caused by multiple types of germs.
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I have taken oral antibiotics for more than 24 hours after my blood test results were finalized.
Select...
I am currently experiencing septic shock with a confirmed infection.
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I need my catheter removed due to infection signs.
Select...
My care goal is comfort, not cure.
Select...
My infection is resistant to the antibiotic ceftriaxone.
Select...
My doctor says I need my central line taken out.
Select...
I need another blood test due to a serious infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Desirability of Outcome Ranking (DOOR) Ordinal Scale which incorporates death, reinfection, readmission, and for some domains incorporates a tie-breaker of new antimicrobial resistance (AMR).
Secondary study objectives
Additional for Individual Domains

Trial Design

5Treatment groups
Active Control
Group I: Central vascular catheter retention VS Central vascular catheter replacementActive Control1 Intervention
Group II: De-escalation VS No De-escalationActive Control1 Intervention
Group III: Oral beta-lactams VS Oral Non-beta-lactamsActive Control1 Intervention
Group IV: Cephalosporin VS Carbapenem for low risk AmpC organismsActive Control1 Intervention
Group V: Routine follow-up blood culture VS No routine follow-up blood cultureActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
671 Previous Clinical Trials
1,562,135 Total Patients Enrolled
6 Trials studying Bacteremia
12,289 Patients Enrolled for Bacteremia
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,373 Previous Clinical Trials
26,516,742 Total Patients Enrolled
2 Trials studying Bacteremia
1,156 Patients Enrolled for Bacteremia
Nick Daneman, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
6 Previous Clinical Trials
4,720 Total Patients Enrolled
4 Trials studying Bacteremia
3,943 Patients Enrolled for Bacteremia
~1667 spots leftby Apr 2027
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