AuthorisedTherapeutic use (Phase IV)Interventional

Phase IV, randomized, open label, parallel groups clinical trial for evaluating the early Stop of antibiotic Treatment in high-risk febrile neutropenic Oncohaematological Paediatric patients (e-STOP 2)

This study, called e-STOP 2, is looking at how safely children with certain types of cancer can stop taking antibiotics when they get a fever and have very few white blood cells (a condition called febrile neutropenia). These children are at high risk of infection. The study aims to find out if stopping antibiotics earlier, compared to the usual longer treatment, is just as effective and safe. Doctors will compare a group of children who stop antibiotics early with a group who get the standard longer course. They will be checking how well the children recover from their fever and low white blood cell count over 28 days.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Enrolment target

136

Start

05 May 2026

Infectious diseases

What is this study about?

When children with blood cancers are having treatment, their immune system can become very weak, leading to a condition called 'neutropenia'. This means they have very low levels of certain white blood cells (neutrophils) that fight infection. If they also develop a fever, doctors call this 'febrile neutropenia', and it's a serious concern because they can get infections easily.

Currently, these children usually receive antibiotics for a longer period to prevent and treat potential infections. This study, called e-STOP 2, wants to see if it's safe to stop these antibiotic treatments earlier than usual for some children. The aim is to reduce the amount of time children spend on strong antibiotics, which can have side effects and contribute to antibiotic resistance over time.

The study will involve two groups of children. One group will continue with the standard antibiotic treatment, and the other group will stop their antibiotics earlier if they are recovering well. Doctors will carefully monitor both groups for 28 days to make sure that stopping antibiotics early is just as safe and effective as the current approach. They'll be looking at how quickly children recover and if any new infections or problems arise.

Key takeaways

Tests early stopping of antibiotics for children with cancer.
Aims to see if shorter antibiotic courses are safe.
Compares early stop with standard, longer treatment.
Focuses on children with fever due to low white blood cells.
Could reduce time spent on strong antibiotics.

Who may be eligible?

This study is looking for both boys and girls who are 18 years old or older. The study focuses on people who have certain types of blood cancer and develop a fever because their immune system is weakened by their cancer treatment.

More specific details about various aspects, such as the exact type of cancer, the current stage of their treatment, or other medical conditions, would need to be discussed with a doctor, as these can affect whether someone is suitable for the study.

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 type of blood cancer (oncohaematological disease)?
Have you developed a fever because your white blood cell count is low (febrile neutropenia)?
Are you able to attend regular check-ups and blood tests?

Answer every question to see your result.

What does participation involve?

If you take part in this study, the main difference will be how long you take antibiotics for your fever if you develop low white blood cells. You will either continue with the usual longer course of antibiotics or, if you're recovering well, you might stop them earlier. Doctors will closely monitor your health for 28 days after an episode of fever and low white blood cells.

This will involve regular check-ups, blood tests, and possibly other tests like urine cultures or scans, just like you would usually have during cancer treatment. The doctors will monitor your temperature, vital signs, and overall condition. All these checks are performed to ensure your safety and to gather information about your recovery.

Potential risks and benefits

Taking part in this study could potentially benefit you by reducing the amount of time you are on strong antibiotics, which might lower the risk of side effects or antibiotic resistance. However, there's a potential risk that stopping antibiotics early could lead to an infection recurring or new complications, which is why your health will be very closely watched. You have the right 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
Spain

Common questions

What is 'febrile neutropenia'?

It's when someone with a weakened immune system (often due to cancer treatment) gets a fever because they have very few white blood cells to fight infection.

What kind of children are eligible for this study?

The study is for young people aged 18 and over who have certain blood cancers and experience a fever due to low white blood cells.

Will I still get antibiotics if I'm in the study?

Yes, everyone in the study will get antibiotics, but some will stop them earlier if they are recovering well, while others will take them for the usual amount of time.

What is the main goal of this study?

The main goal is to find out if it's just as safe to stop antibiotics earlier for children with febrile neutropenia, compared to taking them for a longer period.

How long will I be monitored for in the study?

Doctors will keep a close eye on your health for 28 days after an episode of fever and low white blood cells.