AuthorisedTherapeutic use (Phase IV)Interventional

Antibiotic Prophylaxis in Hematopoietic Stem Cell Transplantation: a Randomised Controlled Trial - The ANTURA trial

A donor stem cell transplant can cure many blood cancers and immune conditions. However, the treatment temporarily wipes out your immune system. This leaves you at high risk of serious bacterial blood infections during the first few weeks. The ANTURA trial is looking at whether giving an antibiotic called levofloxacin before infections start can protect patients. Half the participants will receive levofloxacin, and the other half will receive a dummy medicine called a placebo. Doctors will track whether the antibiotic reduces blood infections, hospital stays, and complications in the first 30 days. They will also follow patients for up to a year to check overall recovery. The goal is to learn whether routine antibiotics improve safety or if they carry unnecessary risks, such as bowel infections or antibiotic resistance.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

HUS-yhtymae

Enrolment target

150

Start

18 Sep 2026

Primary immunodeficiencies and other non‑malignant disorders treated with allogeneic hematopoietic stem cell transplantation.(acute leukemias, myelodysplastic syndromes, lymphomas, and other malignant disorders for which allogeneic HSCT is indicated)

What is this study about?

A stem cell transplant using cells from a donor (known as an allogeneic transplant) is an intensive treatment used for conditions such as leukaemia, lymphoma, and severe immune problems. Before receiving the new cells, patients have chemotherapy or radiotherapy. This treatment clears away unhealthy cells, but it also destroys the white blood cells that normally fight off illness. For several weeks, the body is left almost completely without an immune system, making bloodstream infections a major danger.

Doctors often wonder about the best way to protect patients during this vulnerable time. Some hospitals give antibiotics routinely to stop infections before they begin. Others prefer to wait and only give antibiotics if a patient develops a fever. Giving antibiotics early might stop dangerous bugs, but it can also cause side effects, upset the gut, and lead to bacteria becoming resistant to treatments.

The ANTURA trial aims to answer this question clearly. It compares the antibiotic levofloxacin against an inactive dummy treatment (placebo). By comparing both groups, researchers hope to see whether preventive antibiotics truly save lives and stop severe infections, or whether waiting to treat fevers as they arise is just as safe.

Key takeaways

The trial tests whether the antibiotic levofloxacin stops serious blood infections after a donor stem cell transplant.
Participants will be randomly chosen to receive either levofloxacin or an inactive dummy treatment (placebo).
Study treatment lasts during your transplant stay and for up to 30 days afterwards.
If you develop a fever or infection at any point, you will immediately receive standard antibiotic treatment.
You will be monitored for up to one year to track your overall health and recovery.

Who may be eligible?

This trial is open to adults aged 18 and over who are scheduled to have a donor stem cell transplant. This includes people being treated for blood cancers, such as acute leukaemia, lymphoma, or myelodysplastic syndromes, as well as those with non-cancer conditions like severe inherited immune problems.

You cannot choose which group you are in, and you will need to be well enough to take part in the trial procedures alongside your standard transplant care. Your transplant team will look closely at your medical history, kidney function, and any known allergies to antibiotics to make sure this trial is safe for you.

If you already need ongoing, strong antibiotics for an active infection before your transplant begins, you might not be able to join. Your doctor can explain whether this applies to your situation.

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.

I am aged 18 or older.
I am scheduled to have a stem cell transplant using cells from a donor (allogeneic transplant).
I have a blood cancer (such as leukaemia or lymphoma) or an immune system disorder.
I am able to take either oral tablets or medicine through a vein.
I do not have a known severe allergy to quinolone antibiotics like levofloxacin.

Answer every question to see your result.

What does participation involve?

If you take part, you will be placed into one of two groups by chance (randomly). One group receives the antibiotic levofloxacin, and the other receives a matching dummy medicine (placebo). Neither you nor your doctor will know which one you are receiving. The medicine is given either as a tablet or through a drip into your vein during your stay in hospital.

You will take the study medicine during your transplant preparation and for up to 30 days afterwards, or until your white blood cell count recovers. Throughout this time, your medical team will run regular blood tests and monitor you closely for any signs of fever or infection.

After you leave hospital, the team will check in on your health at 100 days and again at 12 months after your transplant. These checks can usually be done during your normal follow-up clinic visits, meaning you should not need many extra hospital trips.

Potential risks and benefits

Taking part may lower your chance of getting a serious bacterial infection if you receive the active antibiotic. However, levofloxacin can cause side effects such as nausea, diarrhoea, tendon pain, or gut infections like Clostridioides difficile. If you receive the placebo, you will not get these antibiotic side effects, but you may still get an infection. If you develop a fever at any point, your doctors will immediately give you standard antibiotics to protect you. Taking part is entirely voluntary, and you can change your mind and leave the trial at any time 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
Finland

Common questions

What is a placebo?

A placebo is a dummy treatment designed to look just like the real medicine, but with no active ingredients. It helps doctors see if changes in health are really caused by the study drug.

What happens if I get a fever during the trial?

Your safety is the top priority. If you develop a fever or show any signs of infection, your team will immediately start standard, proven antibiotics to treat it, regardless of which study group you are in.

How is the trial medicine given?

It can be given as a tablet to swallow or as a liquid through your drip (intravenous line), depending on how well you can swallow during your transplant.

Will taking part delay my stem cell transplant?

No. The study runs alongside your normal transplant plan and will not delay your treatment schedule.

Can I leave the study if I change my mind?

Yes. You can leave the study at any time without giving a reason. Your doctors will continue to give you the best available standard care.