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Antibiotic

Treatment Strategies for Bacterial Blood Infections

N/A

Recruiting

Led By Rob Fowler, 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

No Placebo-Only Group

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.

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I am currently experiencing septic shock with a confirmed infection.

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I need my catheter removed due to infection signs.

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My care goal is comfort, not cure.

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My infection is resistant to the antibiotic ceftriaxone.

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My doctor says I need my central line taken out.

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I need another blood test due to a serious infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

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