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Early Stopping of Antibiotic Treatment in Children with Cancer and Febrile Neutropenia

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What is this study about?

This clinical trial is being done in children and teenagers with cancer who have febrile neutropenia, a condition in which the body has a fever while the number of infection-fighting white blood cells is very low. The study looks at the safety of stopping antibiotic treatment earlier than usual when there is no proven deep bacterial infection and the child is improving, with the fever going away, the condition staying stable, and blood tests showing low signs of inflammation. The antibiotics used in the study include cefepime, teicoplanin, metronidazole, meropenem, tazobactam, vancomycin, levofloxacin, ciprofloxacin, ceftazidime, amikacin, and piperacillin, given by mouth or through a vein.

The study compares two groups in a random way. In one group, antibiotic treatment is stopped earlier, while in the other group it is continued in the usual way. The child is followed for about 28 days after the start of the fever episode to see how the illness develops and whether any serious infection or other major problem appears. During this time, medical staff monitor symptoms, fever, blood test results, and any side effects or new infections.

The purpose of the study is to find out whether stopping antibiotics earlier is safe in this situation. The trial includes children with cancer and infectious diseases-related fever episodes linked to low white blood cell counts, but it is focused on fever episodes without a confirmed bacterial infection.

Who Can Join the Study?

  • The patient must be 18 years of age or younger.
  • The patient must be expected to have prolonged neutropenia, meaning a low number of neutrophils, a type of white blood cell, for more than 7 days.
  • The patient must have one of the following conditions and treatment situations:
    • Acute myeloblastic leukaemia at any stage of chemotherapy.
    • Acute lymphoblastic leukaemia during induction, consolidation, or intensification treatment phases.
    • Biphenotypic leukaemia at any stage of chemotherapy.
    • Lymphoblastic lymphoma during induction and consolidation phases.
    • B-cell cancer receiving high-intensity chemotherapy.
    • Anaplastic lymphoma receiving high-intensity chemotherapy.
    • Solid tumour receiving high-intensity chemotherapy.
    • Relapsed leukaemia at any stage of treatment.
  • The patient and/or parent(s) or legal representative must be able to read and write well enough to understand the study and give consent.
  • The patient and/or parent(s) or legal representative must be considered reliable and able to follow the study plan.
  • The patient must have had an episode of febrile neutropenia, meaning:
    • A single axillary temperature of at least 38.0°C (temperature measured in the armpit), and
    • An absolute neutrophil count (ANC) below 500 neutrophils/mm³, or expected to drop below this level within the next 48 to 72 hours.
  • Antibiotic treatment must have been started for the current febrile neutropenia episode.
  • Routine infection-prevention antibiotics are allowed.
  • For patients with acute myeloblastic leukaemia included in the CHIP-AML-2022 protocol, teicoplanin given 3 days per week is allowed.
  • At the start of the febrile neutropenia episode, the patient must have a low risk of invasive bacterial infection, meaning all of the following:
    • CRP below 9 mg/dL (CRP is a blood test that measures inflammation).
    • PCT below 0.5 ng/mL (PCT, or procalcitonin, is a blood test that can rise with bacterial infection).
    • No low blood pressure (absence of hypotension).
  • At 48 to 72 hours after the febrile neutropenia episode, there must be no proven or suspected bacterial infection, meaning:
    • No bacteria found in relevant clinical samples.
    • No signs, symptoms, or imaging findings suggesting a local or invasive infection.
  • If a microorganism is found, it may still be acceptable if it is judged to be a contaminant, meaning a germ that likely got into the sample by accident, and there are still no clinical, laboratory, or imaging signs of bacterial infection.
  • At 48 to 72 hours after the febrile neutropenia episode, the patient must be doing well, meaning:
    • No fever for more than 48 hours, with axillary temperature below 38°C.
    • Haemodynamically stable, meaning blood circulation and vital signs are stable.
    • A stable PEWS score, which is a paediatric early warning score used to monitor a child’s condition.
  • At the time of randomisation, the patient must have CRP below 5 mg/dL, or CRP below 9 mg/dL with PCT below 0.5 ng/mL, and the test results must be going down.
  • At the time of randomisation, the patient must still have an ANC below 500 neutrophils/mm³.
  • Signed informed consent must be provided by the patient and/or parent(s) or legal representative(s).

Who Cannot Join the Study?

  • Being treated with an antibiotic at the start of the fever and low white blood cell episode that is different from the preventive antibiotic already being used.
  • Receiving empiric antibiotic treatment that does not follow international guidelines (this means the first antibiotic treatment chosen does not match the accepted medical recommendations).
  • Having a poor early clinical course in the first 12 hours, such as hemodynamic instability (blood pressure or circulation not being stable), admission to the PICU (pediatric intensive care unit, the intensive care unit for children), or death.
  • Already being actively enrolled in this same study when the current fever and low white blood cell episode begins.
  • Being actively enrolled in another clinical trial that, in the investigators’ opinion, could affect the study results.
  • Having any other medical condition that, in the investigators’ opinion, makes the study unsafe, unsuitable, or difficult to evaluate correctly.
  • Being pregnant.
  • Being breastfeeding.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Fknklvcil Pvwd Lg Irutjkyztnmef Bzzhceqma Dcw Hdkvcfkr Uqgnjskzfnhoq Ln Ptc Madrid Spain
Hcgfmryv Vudl dzqzsvht Barcelona Spain

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Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.03.2026

Trial locations

Investigated drugs:

Cefepime is an antibiotic given by vein. It is used in the trial to help treat or prevent serious bacterial infections during fever and low white blood cell counts in children with cancer.

Teicoplanin is an antibiotic given by vein. It is used to fight certain types of bacteria, especially some that can cause infections in the blood, skin, or other parts of the body.

Metronidazole is an antibiotic that can be given by mouth or by vein. It is used against certain bacteria, especially those that grow without oxygen, and may be used to cover possible infection during the febrile neutropenia episode.

Meropenem is a strong antibiotic given by vein. It is used to treat a wide range of serious bacterial infections and is often chosen when doctors need broad protection quickly.

Tazobactam is given by vein with another antibiotic in the trial. It helps protect the main antibiotic from being broken down by some bacteria, so the treatment can work better against resistant germs.

Vancomycin is an antibiotic given by vein. It is used for certain hard-to-treat bacteria, including some that are resistant to other antibiotics.

Levofloxacin is an antibiotic that can be given by mouth or by vein. It is used to treat or prevent bacterial infections by stopping bacteria from growing.

Ciprofloxacin is an antibiotic that can be given by mouth or by vein. It helps treat or prevent infections caused by susceptible bacteria.

Ceftazidime is an antibiotic given by vein. It is used to treat serious infections caused by many types of bacteria, especially in patients who are at higher risk of infection.

Amikacin is an antibiotic given by vein. It is used to treat serious bacterial infections, often when doctors want strong protection against certain resistant bacteria.

Piperacillin is an antibiotic given by vein. It is used to treat a broad range of bacterial infections and is part of strong hospital treatment for high-risk infection episodes.

Investigated diseases:

Febrile neutropenia – This is a condition in which a person has fever while the number of neutrophils, a type of white blood cell, is very low. It develops most often after cancer treatment weakens the bone marrow and lowers the body’s ability to fight infection. The fever may appear suddenly and can be the first sign of infection or inflammation. Over time, it may resolve without a clear cause, or it may be followed by a proven bacterial, viral, or fungal infection. The condition may remain uncomplicated when the fever settles and no specific infection is found.

Trial ID:
2025-524264-38-00
Protocol code:
AB.OH.2025
Trial Phase:
Therapeutic confirmatory (Phase III)

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