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Study on Posaconazole and Fluconazole for Preventing Fungal Infections in Patients with Acute Myeloid Leukemia

Verified siteRegistered drugNo placebo
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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 patients with acute myeloid leukemia (AML), a type of cancer that affects the blood and bone marrow. The study is investigating the effectiveness of two medications, fluconazole and posaconazole, in preventing fungal infections in these patients. Fungal infections can be a serious complication for individuals with AML, especially during treatment periods when their immune systems are weakened.

The purpose of the study is to determine if posaconazole is more effective than fluconazole in reducing the risk of invasive mold infections, which are a type of fungal infection. Participants in the study will be randomly assigned to receive either posaconazole or fluconazole as a preventive measure. Some participants may receive a placebo, which is a substance with no active medication. The treatment period will last up to 180 days, during which the occurrence of fungal infections will be monitored.

Throughout the study, participants will be closely observed for any side effects or adverse reactions to the medications. The study aims to provide valuable information on the best approach to prevent fungal infections in patients with acute myeloid leukemia, ultimately improving their treatment outcomes and quality of life. The trial is expected to conclude by the end of 2025.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to receive either fluconazole or posaconazole as part of the trial. This process is double-blinded, meaning neither you nor the researchers will know which medication you are receiving to ensure unbiased results.

  2. Step 2

    Medication administration

    If you are assigned to fluconazole, you may receive it in different forms: as a 50 mg or 200 mg hard capsule for oral use, or as a 2 mg/ml solution for intravenous use. The specific dosage and frequency will be determined by the study protocol.

    If you are assigned to posaconazole, you may receive it as a 40 mg/ml oral suspension or a 100 mg gastro-resistant tablet. The specific dosage and frequency will be determined by the study protocol.

  3. Step 3

    Treatment period

    The treatment period lasts for up to 180 days. During this time, you will receive the assigned medication to help prevent fungal infections. Regular monitoring will be conducted to assess your health and the effectiveness of the medication.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, you will undergo regular health assessments. These may include blood tests, physical examinations, and other necessary evaluations to monitor for any potential side effects and to ensure your safety.

  5. Step 5

    End of treatment

    At the end of the 180-day treatment period, a final assessment will be conducted to evaluate your overall health and the outcomes of the trial. This will help determine the effectiveness of the medication in preventing fungal infections.

Who can join the trial?

4 criteria

  • Signed informed consent according to national/local regulations. This means you agree to participate in the study after being informed about it.
  • Age 18 years or older.
  • Diagnosis of AML or MDSit. These are types of blood disorders. You must be receiving an intensive chemotherapy treatment, which can include induction, consolidation, or salvage chemotherapy.
  • Planned hospital admission for the duration of the neutropenic phase. This is a period when your white blood cell count is very low (ANC less than 500 cells/mm3), making you more vulnerable to infections.

Who cannot join the trial?

7 criteria

  • Patients who are not diagnosed with acute myeloid leukemia (AML) cannot participate. AML is a type of cancer that affects the blood and bone marrow.
  • Patients who are not in the age range of 18 to 65 years old cannot participate.
  • Patients who are not able to follow the study procedures or take the study medication as directed cannot participate.
  • Patients who have a known allergy or sensitivity to the study medications, posaconazole or fluconazole, cannot participate. These are medications used to prevent fungal infections.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are participating in another clinical trial cannot participate.
  • Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate cannot participate.
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Investigated drugs

  • Posaconazole

    is a medication used to prevent fungal infections, especially in people with weakened immune systems, such as those undergoing treatment for acute myeloid leukemia. It works by stopping the growth of fungi, helping to protect patients from serious infections during their treatment period.

  • Fluconazole

    is another medication used to prevent and treat fungal infections. It is often used in patients with weakened immune systems to help prevent infections caused by fungi. In this trial, it is being compared to posaconazole to see which is more effective in preventing mold infections in patients with acute myeloid leukemia.

What is already known about the treatment

  • Posaconazole

    Posaconazole is administered orally or intravenously and is used to prevent fungal infections in patients with acute myeloid leukemia. It is well-established in medical literature as an effective antifungal agent. The main therapeutic use of posaconazole is to prevent invasive mold infections, which are serious fungal infections. At the molecular level, posaconazole works by inhibiting an enzyme that fungi need to produce a vital component of their cell membranes, thus stopping their growth. It is classified as an antifungal medication.

  • Fluconazole

    Fluconazole is available in oral and intravenous forms and is used to prevent fungal infections in patients with acute myeloid leukemia. It is a widely recognized antifungal medication in medical practice. The primary therapeutic indication for fluconazole is to prevent fungal infections, although it is less effective against mold infections compared to posaconazole. Fluconazole works by interfering with the fungal cell membrane formation, which is essential for the fungi's survival. It belongs to the class of antifungal drugs.

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. The disease can advance quickly, requiring prompt medical attention. AML is more common in adults and can vary in its progression and severity. The exact cause of AML is not fully understood, but it involves genetic mutations in the blood-forming cells.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517211-79-00Protocol codePTX3-AMLEstimated enrolment402 patientsSponsorCentre Hospitalier Universitaire Vaudois

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