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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country	Status
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Hqjcyiu Hsqgj Mvokrc &ozkvxl 1 rya Gchyuvg Ezrwya	Creteil	France

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	03.03.2020
France	Not yet recruiting	03.03.2020

Trial locations

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.

Investigated diseases:

Fungal infection

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 ID:

2024-517211-79-00

Protocol code:

PTX3-AML

NCT ID:

NCT03828773

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?