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RecruitingNAINTERVENTIONAL

A Platform Trial for Gram Negative Bloodstream Infections

The BALANCE+ study is checking out various treatment approaches for serious blood infections caused by specific types of bacteria. These infections are called Gram-negative bloodstream infections. Doctors want to discover the best ways to treat them to help people recover faster and prevent bacteria from becoming resistant to antibiotics. Researchers are comparing different treatment strategies, such as when to switch from strong intravenous antibiotics to oral ones, how to manage catheters, and if follow-up blood tests are always needed. They are carefully monitoring how different treatments work to see which ones are most effective and safest for patients. This study is an important step in improving care for these infections across Canada and beyond.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Sunnybrook Health Sciences Centre
Enrolment target
2,500
Start
24 Apr 2024
Estimated completion
01 Apr 2028

What is this study about?

Imagine you have a serious infection in your blood, caused by a type of germ called Gram-negative bacteria. These infections can make people very unwell. Doctors are always looking for the best ways to treat them, especially as some germs are becoming harder to treat with existing medicines. That's where the BALANCE+ study comes in.

BALANCE+ is a large, ongoing study that’s trying out different ways to manage these infections. Think of it like a big umbrella under which several smaller studies are happening at the same time. Each smaller study asks a specific question, like: Is it better to switch from strong hospital antibiotics to oral ones sooner? Or, how should we best manage tubes (catheters) that go into veins during treatment? The goal is to find clearer answers so doctors can give patients the most effective and safest care possible.

This study is really important because it aims to not only help patients get better but also to slow down the problem of antibiotic resistance. This is when germs learn to resist the medicines we use to fight them, making infections much harder to treat. By finding smarter ways to use antibiotics, BALANCE+ hopes to protect these vital medicines for everyone's future health.

Key takeaways

  • BALANCE+ is a study about improving treatment for serious bloodstream infections.
  • It aims to find the most effective and safest ways to use antibiotics.
  • The study helps fight against antibiotic resistance.
  • Participation involves receiving care guided by different treatment strategies.
  • You can withdraw from the study at any time.
  • Your care will always be a top priority.

Who may be eligible?

To be considered for the BALANCE+ study, you would generally need to be in a participating hospital and have a confirmed Gram-negative bacterial infection in your blood. However, this study might not be suitable for everyone.

You wouldn't be able to join if your care is focused on comfort rather than active treatment, or if doctors don't expect you to survive for more than 72 hours. Also, if you've been part of this study before, or if there's a specific reason why none of the study's treatment options would work for you, then you wouldn't be eligible.

Beyond these general rules, each specific part of the study (what we call a 'domain') has its own eligibility checks. For example, if you're in a part of the study looking at switching from IV to oral antibiotics, there might be specific requirements about the timing of your treatment or if certain medications would conflict with others.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Am I in a hospital taking part in the study?
  2. Do I have a Gram-negative bacterial infection in my blood?
  3. Is my medical care focused on getting better, not just comfort?
  4. Am I expected to survive for more than 72 hours?
  5. Have I participated in this specific study before?
Answer every question to see your result.

What does participation involve?

If you join the BALANCE+ study, you'll continue to receive care for your bloodstream infection, but the doctors might use one of the specific treatment approaches being tested. For example, they might try a different type of antibiotic, decide whether to switch you to oral antibiotics at a particular time, or choose a certain way to manage your central line (a special IV tube).

The treatments you receive will be part of your routine hospital care, but the study will help doctors decide which treatment is best for you based on the research questions. You won't have extra visits just for the study, as it's designed to fit into your normal hospital stay. Doctors will collect information about your health and how you respond to treatment, which involves looking at your medical records and test results. Your participation will last as long as you're receiving care for your infection under the study's guidance. You can ask to leave the study at any time.

Potential risks and benefits

Participating in research always has potential benefits and risks. The main benefit is that you will receive expert medical care for your infection, and your treatment will contribute to important knowledge that could improve care for future patients. There are no major extra risks from being in this study beyond the usual risks of hospital treatment for such an infection, as it's comparing standard and widely accepted medical practices. Any decisions about your care are always made by your medical team with your best interests at heart. Remember, you have the right to withdraw from the study at any time without it affecting the quality of your medical care.

Locations (39)

  • St George Hospital
    Verified postcode
    Kogarah, Australia· Recruiting
  • John Hunter Hospital
    Verified postcode
    New Lambton, Australia· Recruiting
  • Royal Brisbane and Women's Hospital
    Verified postcode
    Herston, Australia· Recruiting
  • Redcliffe Hospital
    Verified postcode
    Redcliffe, Australia· Recruiting
  • Sunshine Coast University Hospital
    Verified postcode
    Sunshine Coast, Australia· Recruiting
  • Monash Medical Center
    Verified postcode
    Clayton, Australia· Recruiting
  • Fiona Stanley Hospital
    Verified postcode
    Murdoch, Australia· Recruiting
  • St John of God
    Verified postcode
    Murdoch, Australia· Recruiting
  • Foothills Hospital
    Verified postcode
    Calgary, Canada· Recruiting
  • Peter Lougheed Centre
    Verified postcode
    Calgary, Canada· Recruiting
  • Rockyview General Hospital
    Verified postcode
    Calgary, Canada· Recruiting
  • South Health Campus
    Verified postcode
    Calgary, Canada· Recruiting

Common questions

What is a Gram-negative bloodstream infection?

It's a serious infection in your blood caused by a specific type of bacteria called Gram-negative bacteria.

Why is this study important for me?

While you receive care for your infection, your participation helps doctors find the best ways to treat these infections, leading to better care for everyone in the future.

Will I get different care than if I wasn't in the study?

Your care will be within standard medical practices, but the study might guide which of several accepted treatments is chosen for you, to help gather evidence on what works best.

Can I leave the study if I change my mind?

Yes, you can decide to stop participating at any time without it affecting your medical care.

What is 'antibiotic resistance'?

It's when bacteria learn to fight off the antibiotics meant to kill them, making infections harder to treat. The study aims to help reduce this problem.

How to find out more

Nick Daneman, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Platform Trial for Gram Negative Bloodstream Infections…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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