RecruitingNAINTERVENTIONAL

Short Antibiotic Treatment in High Risk Febrile Neutropenia

This study explores how long seriously ill cancer patients with low white blood cells (febrile neutropenia) need to take antibiotics. Infections are a big concern for these patients, and while antibiotics are vital, taking them for too long can lead to problems like drug-resistant infections or new infections like C. difficile. Most hospitals currently keep patients on antibiotics until their white blood cells recover, but some new research suggests that stopping them earlier might be safe. This study aims to check if a shorter course of antibiotics is just as safe as the usual longer course in high-risk patients. The goal is to find better ways to use antibiotics, reducing risks while still keeping patients safe from serious infections.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

Start

01 Oct 2023

Estimated completion

28 Feb 2026

Febrile Neutropenia

What is this study about?

When you're having cancer treatment like chemotherapy, your body's ability to fight off infections can be weakened. This is because these treatments can lower the number of white blood cells called neutrophils, which are crucial for your immune system. If your neutrophil count is very low and you get a fever, it's called 'febrile neutropenia,' and it's a serious condition that needs immediate antibiotic treatment to prevent life-threatening infections.

Doctors currently aren't sure exactly how long is best to keep patients on antibiotics in these situations. The standard approach is often to continue antibiotics until your white blood cell count returns to a safer level. However, taking antibiotics for a long time can have its own problems. It can lead to 'superbugs' – bacteria that are hard to kill with usual antibiotics – and can also increase the risk of other infections like C. difficile, which can cause severe diarrhoea, or fungal infections.

This study wants to find out if stopping antibiotics a bit earlier for certain high-risk patients is just as safe and effective as continuing them for longer. There's some early evidence suggesting this might be possible. By finding the right length of antibiotic treatment, we hope to improve care for cancer patients by reducing the risks associated with long-term antibiotic use, while making sure they are still well-protected from dangerous infections.

Key takeaways

This study is for adult cancer patients with fever and low white blood cells.
It compares shorter antibiotic treatment to the usual longer treatment.
The goal is to find out if stopping antibiotics earlier is safe.
Earlier stopping might reduce problems like 'superbugs' and other infections.
Your medical team will monitor you closely throughout the study.
You can discuss any concerns with your doctor at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who are being treated for certain types of acute leukaemia (AML, ALL, or mixed-phenotypic) with chemotherapy, or undergoing a stem cell transplant with conditioning chemotherapy or radiation.

You would also need to have recently developed 'febrile neutropenia.' This means you have a fever (a single temperature of 38.3°C or higher, or two readings of 38.0°C or higher within an hour) and a very low number of infection-fighting white blood cells (neutrophils). Importantly, doctors must not have found any specific infection (like a known bacterial infection or a definite source of infection) that would require longer treatment. Your blood cultures must also be clear.

You can enrol if you have already been on antibiotics for at least 3 days (72 hours), have not had a fever for at least the last 24 hours, and your white blood cell count is still low. You cannot join if you are already in another trial, if you've been on antibiotics for more than 7 days from when your fever started, or if you had a very severe type of infection (septic shock) when your fever began or in the first 72 hours.

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?
Are you currently having treatment for acute leukaemia or a stem cell transplant?
Do you have a fever AND a low white blood cell count recently?
Have you been on antibiotics for at least 3 days and been fever-free for at least 24 hours?
Are doctors sure there isn't a clear source of infection that requires specific treatment?
Have you NOT been on antibiotics for more than 7 days since your fever started?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned to one of two groups: either a shorter course of antibiotics or the standard longer course. This will involve your medical team monitoring you closely, just as they would with your usual care. They will check your temperature, symptoms, and blood tests, particularly your white blood cell counts, regularly. You will still receive all necessary medical attention, regardless of which group you are in. The study itself won't require extra visits or medicine outside of what's already part of your hospital stay for treating febrile neutropenia; it's focused on the timing of stopping your existing antibiotics.

Potential risks and benefits

The main potential benefit is helping to understand if shorter antibiotic treatment is safe and effective, which could reduce side effects and antibiotic resistance in the future. For you, this means you might avoid some risks associated with longer antibiotic use. However, there's always a small risk that stopping antibiotics earlier could lead to an infection getting worse, even though the study is designed to assess if it's safe. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (4)

Alberta Health Services
Verified postcode
Edmonton, Canada· Recruiting
London Health Sciences Centre
Verified postcode
London, Canada· Recruiting
University Health Network
Verified postcode
Toronto, Canada· Recruiting
Vancouver General Hospital
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is febrile neutropenia?

It's when your white blood cell count is very low (due to cancer treatment) and you have a fever. This makes you more vulnerable to serious infections.

Why is it a problem to take antibiotics for too long?

Long-term antibiotic use can lead to bacteria becoming resistant (superbugs), and can also cause other infections like C. difficile or fungal infections.

Will I still get good care if I'm in the shorter antibiotic group?

Yes, you will still receive excellent medical care and close monitoring, with antibiotics adjusted based on your condition, regardless of the group you are in.

What is the purpose of this study?

The study aims to see if stopping antibiotics earlier is as safe as taking them for longer, to find the best way to treat these infections and reduce risks of overuse.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any point, and your decision will not affect the medical care you receive.

How to find out more

Shahid Husain, MD

shahid.husain@uhn.ca 4163404800 Official trial record

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