AuthorisedTherapeutic confirmatory (Phase III)Interventional

A multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients: efficacy and microbiologic safety.

This research study is looking at two types of antibiotics, fosfomycin and ciprofloxacin, to see how well they treat fever in patients with blood cancers. These patients often have a weakened immune system, called neutropenia, after chemotherapy, which makes them very prone to serious infections. The study wants to find out if one of these antibiotics is better than the other at fighting off infections and if they are safe to use. This is a large-scale study, meaning it involves many hospitals, to get clear answers about the best way to help patients through this challenging time after their cancer treatment.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias

Enrolment target

156

Start

21 Jan 2025

Post-chemotherapy neutropenia with high risk of developing infection in patients with acute leukemia undergoing induction autologous or allogeneic hematopoietic stem cell transplantation (HSCT).

What is this study about?

When people are treated for blood cancers like leukaemia, chemotherapy can be very effective at killing cancer cells. However, it also temporarily reduces healthy blood cells, including white blood cells called neutrophils, which are crucial for fighting infections. This condition is called neutropenia, and when a fever occurs during this time, it's known as febrile neutropenia – a serious situation because the body struggles to fight off germs.

This study is comparing two common antibiotics, fosfomycin and ciprofloxacin, to treat febrile neutropenia. Think of antibiotics as special medicines that kill bacteria. The main goal is to see which of these antibiotics is more effective at treating infections and preventing them from becoming worse, while also checking if they are safe to use for patients going through intensive cancer treatment.

Finding the best and safest antibiotic treatment is very important. It can help doctors make better choices for future patients, potentially leading to fewer complications, better recovery, and improved overall health during a very vulnerable time after chemotherapy or a stem cell transplant.

Key takeaways

This study compares two antibiotics for fever in cancer patients with weakened immune systems.
It's for adults with blood cancers having chemotherapy or stem cell transplants.
The goal is to find which antibiotic is most effective and safest.
You'll get close medical monitoring if you join.
Participation is voluntary, and you can leave at any time.

Who may be eligible?

To join this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

You would also need to have a specific type of blood cancer, such as acute leukaemia, and be undergoing intensive treatments like chemotherapy or a stem cell transplant. A key requirement is that you must have developed a fever and weakened immune system (neutropenia) after these treatments, as this is the condition the study aims to treat.

Patients who have already recovered their white blood cell count to certain levels or have already received specific treatments might not be able to join. The study will carefully check your blood test results and medical history to make sure it's the right fit for you.

Quick self-check

Are you 18 years old or older?
Do you have acute leukaemia or another blood cancer?
Are you having chemotherapy or a stem cell transplant?
Have you developed a fever and low white blood cell count (neutropenia) after your treatment?
Do you currently need antibiotic treatment for this fever?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive either fosfomycin or ciprofloxacin. This is like flipping a coin – neither you nor your doctor chooses which medicine you get, ensuring the study is fair. You'll receive this antibiotic treatment for your febrile neutropenia, just as you would normally receive antibiotics, but with closer monitoring.

Throughout the study, the medical team will regularly check your health, take blood samples to monitor your blood counts and any infections, and track how you feel. The study will continue until your immune cell count improves, for a maximum of 60 days from when your white blood cell count dropped, or until your next chemotherapy treatment begins, whichever comes first. If, sadly, a participant passes away, their participation in the study would also end.

Potential risks and benefits

Taking part in a study like this means you would receive close medical attention and monitoring. The potential benefit is that you might receive an antibiotic treatment that is found to be more effective or safer for your condition. However, there's also a chance that the antibiotic you receive might not work as well for you, or you could experience side effects, as with any medication. The doctors will explain all known potential side effects of both medicines. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Spain

Common questions

What is neutropenia?

Neutropenia is when your body has too few white blood cells called neutrophils. These cells are really important for fighting off germs and infections. It often happens after chemotherapy for cancer.

What is febrile neutropenia?

This is when you get a fever while you have neutropenia. It's a serious condition because your body can't fight infections well, so a fever can mean a hidden infection that needs quick treatment.

What are fosfomycin and ciprofloxacin?

These are both types of antibiotics, which are medicines used to treat infections caused by bacteria. This study is comparing them to see which works best for febrile neutropenia.

Will I know which antibiotic I'm getting?

No, in this type of study, participants are randomly assigned to one of the treatments. This helps make the study fair and makes sure the results are reliable.

How long will I be in the study?

Your participation will typically last until your immune cell count improves, up to a maximum of 60 days from when your white blood cell count dropped, or when your next chemotherapy cycle starts, whichever happens first.