Ongoing, recruitingTherapeutic use (Phase IV)Interventional

SAFE study: Stopping Antibiotics after 3 days for the treatment of FEbrile Neutropenia in Haematology patients, a randomized open-label non-inferiority trial

The SAFE study is looking into how long people with a condition called febrile neutropenia need to take antibiotics. Febrile neutropenia is when someone, often a cancer patient, gets a fever and has a very low number of infection-fighting white blood cells. This can make them very vulnerable to serious infections. Currently, there are different ways doctors decide when to stop antibiotics for this condition. This study wants to see if stopping antibiotics after just 3 days is as safe and effective as continuing them for longer, especially in preventing serious health problems like needing intensive care or developing severe blood infections. It's a real-world study using common antibiotics like Imipenem, Meropenem, Cefepime, Ceftazidime, and Piperacillin.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

UZ Leuven

Enrolment target

410

Start

23 Aug 2023

Febrile neutropenia

What is this study about?

When you're undergoing treatment for conditions like cancer, your immune system can sometimes become very weak. This can lead to a condition called 'febrile neutropenia'. This simply means you have a fever and a very low number of a certain type of white blood cell called neutrophils, which are crucial for fighting off germs. Because your body's defences are down, you're at a much higher risk of serious infections, so doctors usually prescribe strong antibiotics straight away.

Currently, there isn't one set rule for how long people with febrile neutropenia need to take these antibiotics. Some doctors might continue them for a longer period, while others might stop them sooner if you're improving. The SAFE study is trying to find out if stopping antibiotics after a short period, specifically 3 days, is just as good and safe as continuing them for longer. This could potentially mean less time on strong medication, which can have its own benefits.

The main goal of this study is to see if reducing the antibiotic treatment period still effectively prevents serious health issues that could arise from infections. These serious issues include things like needing to go into intensive care, developing a life-threatening blood infection (septic shock), or, very sadly, dying. The researchers will follow participants for 42 days after they join the study to track if any of these serious complications occur.

Key takeaways

The SAFE study is researching antibiotic treatment for febrile neutropenia.
It compares a short 3-day antibiotic course with longer standard treatment.
The main goal is to ensure the shorter course is equally safe and effective.
It aims to prevent serious health problems like intensive care admission or severe infections.
The study involves monitoring participants' health for 42 days.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 years or older. There is no upper age limit for joining.

This study is open to both men and women. The specific medical condition that would qualify you to take part is having 'febrile neutropenia'. This means you have both a fever and a very low count of certain white blood cells.

Your doctor will be able to tell you if your specific health situation matches the requirements for this study. They will check all your medical information carefully to make sure it's the right fit for you.

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.

Are you 18 years old or older?
Do you have a fever?
Has your doctor told you that you have a very low white blood cell count (neutropenia)?
Are you comfortable with the idea of potentially stopping antibiotics after 3 days, if medically appropriate for you?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue to receive treatment for your febrile neutropenia as usual. The key difference will be how long your antibiotics are given for. You will either continue with antibiotics for a longer period, as decided by your doctor, or you might be in a group where antibiotics are stopped after 3 days, if you are showing signs of improvement.

Your doctors and nurses will closely monitor your health throughout the study period. This will involve regular checks, including blood tests and assessments of any symptoms you might have. They will be looking out for any signs of new infections or if your original infection gets worse. The main period of observation for this study is 42 days after you agree to participate, during which your health will be tracked.

Potential risks and benefits

Taking part in this study may offer a potential benefit by helping doctors understand the best way to treat febrile neutropenia, which could improve care for future patients. For you, if the shorter antibiotic course is shown to be effective, it might mean less exposure to strong antibiotics, which can have side effects. However, as with any medical study, there's a risk that a shorter course might not be as effective for everyone, potentially leading to more infections or complications. We want to assure you that your safety is the highest priority, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is 'febrile neutropenia'?

It's when you have a high temperature (fever) and a very low number of white blood cells that fight infection. It often happens to people undergoing strong medical treatments like chemotherapy.

Why are doctors looking at different antibiotic treatment lengths?

Doctors want to find the safest and most effective way to treat febrile neutropenia. Using antibiotics for shorter periods, if effective, could reduce side effects and the risk of bacteria becoming resistant to the medication.

Will I know which treatment group I'm in?

Yes, this is an 'open-label' study, meaning both you and your doctors will know if you are assigned to the shorter or longer antibiotic treatment plan.

What kind of 'serious medical complications' are being looked for?

The study is specifically looking to prevent very serious issues like needing intensive care, developing a severe blood infection called septic shock, or, in the worst case, death.

Can I stop participating in the study once I've started?

Yes, absolutely. You have the right to withdraw from the study at any time, for any reason, and it will not affect the medical care you receive.