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Study on Teicoplanin for Preventing Infections in Children with Acute Myeloid Leukemia

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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 focused on studying the use of teicoplanin as a preventive treatment for infections in children diagnosed with Acute Myeloid Leukemia (AML). Acute Myeloid Leukemia is a type of cancer that affects the blood and bone marrow, which is the spongy tissue inside bones where blood cells are made. The study aims to determine if using teicoplanin, a medication given through an injection into a vein, can help reduce the occurrence of certain infections during the treatment of children with newly diagnosed AML.

The study is divided into two phases. In the first phase, the safety of using teicoplanin three times a week will be assessed. In the second phase, the study will evaluate whether this treatment can decrease the occurrence of specific blood infections during the initial treatment of AML. Participants will receive the medication for a maximum period of four weeks. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of teicoplanin.

The trial will monitor various aspects, such as the number of infections, any side effects, and the overall health of the participants during the study. The goal is to gather information on how effective and safe teicoplanin is in preventing infections in children undergoing treatment for Acute Myeloid Leukemia.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after a diagnosis of acute myeloid leukemia (AML) and registration according to the NOPHO-DBH AML 2012 study protocol or a similar protocol.

    Eligibility requires written informed consent from the patient or legal guardians, depending on the patient's age.

  2. Step 2

    Safety run-in phase

    The initial phase focuses on assessing the safety of intravenous (i.v.) teicoplanin as a preventive measure against infections.

    The medication is administered three times per week with intervals of two to three days.

  3. Step 3

    Randomized control phase

    This phase evaluates the effectiveness of i.v. teicoplanin in reducing the occurrence of specific bloodstream infections during AML treatment.

    The primary goal is to monitor the first occurrence of a culture-proven bloodstream infection with viridans group streptococci (VGS).

  4. Step 4

    Medication details

    The medication used is Targocid 400mg, a powder for solution for injection or infusion.

    The administration route is intravenous, which involves delivering the medication directly into a vein.

  5. Step 5

    Monitoring and assessments

    Regular monitoring includes checking for any adverse effects, such as changes in kidney function or hearing.

    Blood cultures are taken to identify any resistant bacteria and to monitor infection-related outcomes.

  6. Step 6

    End of trial

    The trial is expected to conclude by November 30, 2025.

    The duration of participation may vary depending on individual treatment responses and the occurrence of any adverse events.

Who can join the trial?

4 criteria

  • The patient must have been newly diagnosed with acute myeloid leukemia (AML).
  • The patient must be registered and starting treatment according to the NOPHO-DBH AML 2012 study protocol, or a similar protocol that follows consecutively.
  • The patient must be between the ages of 0 and 19 years.
  • There must be a written informed consent provided by the patient and/or their legal guardians, depending on the patient's age. This means that the patient and/or their guardians understand the study and agree to participate.

Who cannot join the trial?

4 criteria

  • Patients who do not have a diagnosis of acute myeloid leukemia (a type of blood cancer) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are not considered part of the vulnerable population selected for the study cannot participate.
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Investigated drugs

Teicoplanin is being studied as a preventive treatment for infections in children with newly diagnosed acute myeloid leukemia (AML). The trial aims to determine if using teicoplanin can reduce the occurrence of certain bloodstream infections during treatment. It is administered intravenously three times a week with intervals of two to three days.

What is already known about the treatment

Teicoplanin – Teicoplanin is administered intravenously, typically three times a week, and is used as a prophylactic treatment to prevent infections in children with newly diagnosed acute myeloid leukemia. It is currently being studied in clinical trials to assess its safety and effectiveness in reducing bloodstream infections caused by certain bacteria during leukemia treatment. The main therapeutic indication for teicoplanin in this context is infection prevention in pediatric leukemia patients. At the molecular level, teicoplanin works by inhibiting bacterial cell wall synthesis, which helps to stop the growth and spread of bacteria. It is classified as a glycopeptide antibiotic.

Investigated diseases

Acute Myeloid Leukemia – Acute Myeloid Leukemia (AML) is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. These abnormal cells accumulate in the bone marrow, interfering with the production of normal blood cells. As the disease progresses, it can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding due to the lack of healthy blood cells. AML can occur at any age but is more common in adults. The disease is classified into different subtypes based on specific genetic and chromosomal abnormalities. The progression of AML can vary, with some cases advancing quickly while others may develop more slowly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506546-23-00Protocol codeSP_MH19PROEstimated enrolment128 patientsSponsorPrincess Maxima Center For Pediatric Oncology

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).