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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study entry and treatment assignment

    When you join the study, you are placed into one of two groups by chance. The study is randomized, which means the treatment group is assigned randomly.

    The study is open label, which means the treatment you receive is known. The groups are followed in parallel, which means both groups are observed during the same study period.

  2. Step 2

    Initial antibiotic treatment during the febrile neutropenia episode

    You receive one of the study antibiotic options during the episode of febrile neutropenia, which means fever with a low number of white blood cells that help fight infection.

    The possible medicines and doses listed in the study are: cefepime 150 mg/kg by intravenous infusion; teicoplanin 12 mg/kg by intravenous infusion; metronidazole 30 mg/kg by mouth or 30 mg/kg by intravenous infusion; meropenem 120 mg/kg by intravenous infusion; tazobactam 37.5 mg/kg by intravenous infusion; vancomycin 60 mg/kg by intravenous infusion; levofloxacin 20 mg/kg by mouth or 20 mg/kg by intravenous infusion; ciprofloxacin 40 mg/kg by mouth or 30 mg/kg by intravenous infusion; ceftazidime 150 mg/kg by intravenous infusion; amikacin 22.5 mg/kg by intravenous infusion; and piperacillin 400 mg/kg by intravenous infusion.

    Intravenous infusion means the medicine is given through a vein.

  3. Step 3

    Assessment at 48 to 72 hours

    At 48 to 72 hours after the febrile neutropenia episode begins, your condition is checked to see whether the fever has gone away and whether you are clinically stable. Clinically stable means your general condition is not worsening.

    At this time, blood tests are checked, including CRP and PCT. CRP means C-reactive protein, a marker of inflammation. PCT means procalcitonin, another blood marker that can rise with infection.

    Your ANC is also checked. ANC means absolute neutrophil count, which is the number of infection-fighting white blood cells.

  4. Step 4

    Decision on whether antibiotics are stopped early

    If you have no proven invasive bacterial infection, your fever has resolved, you are clinically stable, and your blood results meet the study limits, the study may stop antibiotic treatment early.

    The blood result limits are: CRP less than 5 mg/dL, or CRP less than 9 mg/dL together with PCT less than 0.5 ng/mL, and ANC below 500/mm³ at 48 to 72 hours.

    If you are in the group that does not stop treatment early, antibiotic treatment continues according to the study plan.

  5. Step 5

    Follow-up until day 5, if applicable

    If needed, additional checks are done up to day 5 after the febrile neutropenia episode begins.

    At this stage, blood tests may be repeated, including complete blood count, blood chemistry, CRP, and PCT.

    Other information recorded during the trial includes the number of days with fever, the number of days with low neutrophil count, and the type and number of days of antimicrobial medicines received.

  6. Step 6

    Monitoring during the trial

    During the trial, your medical team records your clinical condition, vital signs, physical examination findings, and any admission to a pediatric intensive care unit, which is a unit for very closely monitored care.

    The study also records microbiology results such as blood cultures and urine cultures, and other tests if they are done, such as nasopharyngeal swab, cerebrospinal fluid culture, or imaging tests like x-ray, ct, mri, or ultrasound.

    The study records any side effects or other unwanted medical events, as well as any other medicines you are taking at the same time.

  7. Step 7

    Final assessment at 28 days

    At 28 days after the start of the febrile neutropenia episode, your outcome is assessed.

    The main study result is whether your episode ended without any of the following: death from any cause, admission to the pediatric intensive care unit, sepsis, a bacterial infection proven by a test, a bacterial infection found by symptoms and signs, or pneumonia confirmed by imaging.

    At this time, blood tests are checked again, including complete blood count, blood chemistry, CRP, and PCT.

Who can join the trial?

29 criteria

  • 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 trial?

8 criteria

  • 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.
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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.

What is already known about the treatment

  • Cefepime

    Cefepime is given as an intravenous infusion, which means it is delivered slowly into a vein by a healthcare professional. It is a well-known antibiotic still used in modern medicine, especially in hospital care for serious infections. It belongs to the cephalosporin group of antibiotics and is used mainly to treat severe bacterial infections such as pneumonia, bloodstream infections, and infections in people with weak immune systems. It works by blocking the bacteria’s cell wall building process, which weakens and kills the bacteria.

  • Teicoplanin

    Teicoplanin is given by intravenous infusion in hospital settings under medical supervision. It is an established antibiotic in medical practice and is commonly discussed in medical literature for treating serious infections caused by certain gram-positive bacteria. It is used mainly for infections such as bloodstream infections, skin and soft tissue infections, bone infections, and infections caused by resistant bacteria like methicillin-resistant staphylococci. It works by stopping bacteria from building their cell wall, which prevents them from growing and leads to their death.

  • Metronidazole

    Metronidazole can be given by mouth or by intravenous infusion, depending on the patient’s condition and the severity of the infection. It is a long-standing and widely used medicine in clinical practice and remains important in medical literature for infections caused by certain bacteria and parasites. It is used for abdominal infections, infections in the mouth and teeth, and other infections where germs grow best without oxygen. It works by entering the germ and damaging its genetic material, which stops the germ from multiplying and kills it.

  • Meropenem

    Meropenem is administered as an intravenous infusion in hospital care. It is a modern, widely used broad-spectrum antibiotic and is well established in medical practice for severe infections. It belongs to the carbapenem group of antibiotics and is used for serious infections such as sepsis, complicated abdominal infections, and infections in patients with low immunity. It works by blocking bacteria from making their cell wall, which causes the bacteria to break down and die.

  • Tazobactam

    Tazobactam is given by intravenous infusion, usually together with another antibiotic. It is a well-known medicine in medical practice and literature, but it is not usually used alone because its main role is to support other antibiotics. It belongs to the beta-lactamase inhibitor group and is used to help treat infections caused by bacteria that try to break down certain antibiotics. It works by blocking bacterial enzymes that destroy antibiotics, allowing the partner antibiotic to work better.

  • Vancomycin

    Vancomycin is administered as an intravenous infusion under close medical supervision. It is a classic and still important antibiotic in modern medicine, especially for serious resistant bacterial infections. It is used mainly for severe infections caused by gram-positive bacteria, including some resistant strains, as well as bloodstream, bone, and lung infections. It works by attaching to a key part of the bacterial cell wall building material, which prevents the bacteria from forming a strong wall and causes them to die.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524264-38-00Protocol codeAB.OH.2025Estimated enrolment136 patientsSponsorFundacio Hospital Universitari Vall D’Hebron Institut De Recerca

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