Study on Fluconazole for Children and Adolescents with Fungal Infections

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What is this study about?

This clinical trial is focused on studying the effects of the medication fluconazole in children and adolescents aged 2 to 18 years who are dealing with invasive fungal infections. These infections are serious and can affect various parts of the body. The study aims to find the best way to dose fluconazole for young patients, whether it is given by mouth or through an intravenous infusion, which is a method of delivering medication directly into the bloodstream.

Participants in the study will receive fluconazole in different forms, including capsules, oral suspension, or as a solution for infusion. The study will observe how the body processes the medication, which is known as pharmacokinetics. This includes understanding how fluconazole is absorbed, distributed, and cleared from the body. The goal is to ensure that the medication is used effectively and safely in young patients.

The study will take place over a period of time, with participants receiving fluconazole either as a preventive measure or as a treatment for their fungal infections. The researchers will collect data to help improve the dosing guidelines for fluconazole in children and adolescents, ensuring that the medication is both effective and safe for this age group. The study will also explore factors that might affect how the medication works, such as body weight and kidney function.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. The study aims to improve the dosing regimen of fluconazole for children and adolescents aged 2-18 years with invasive fungal infections.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying that you are between 2 and 18 years old, are being treated with fluconazole for a fungal infection, and have a central venous catheter or arterial line for blood sampling.

3 medication administration

You will receive fluconazole either orally or through an intravenous infusion. The specific form and dosage will depend on your treatment plan. Options include 50 mg capsules, 100 mg capsules, a 2 mg/ml solution for infusion, or a 10 mg/ml oral suspension.

4 ongoing monitoring

Throughout the study, regular monitoring will occur to assess how your body processes the medication. This involves blood tests to measure the concentration of fluconazole in your system.

5 data collection

Data will be collected on various factors that might influence how fluconazole works in your body, such as kidney function and body weight. This information helps in understanding the medication’s effectiveness and safety.

6 completion of study

The study is expected to conclude by September 30, 2025. Upon completion, you will be informed about the findings and any implications for your treatment.

Who Can Join the Study?

The patient must be treated with fluconazole, which is a medication used to prevent or treat a serious fungal infection.
The patient must be between the ages of 2 and 18 years old on the day they first receive fluconazole.
The patient must have a central venous catheter or an arterial line, which are special tubes used to take blood samples or give medications directly into the bloodstream.

Who Cannot Join the Study?

Patients with a current or recent fungal infection cannot participate.
Patients who are not within the age range of 2 to 18 years are excluded.
Patients who are not able to follow the study procedures or take the study medication as required will be excluded.
Patients who have any other medical condition that the study doctors think might make it unsafe for them to participate will not be allowed to join.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who are participating in another clinical trial at the same time are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Prinses Maxima Centrum voor Kinderoncologie B.V.	Utrecht	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.03.2022

Trial locations

Investigated drugs:

Fluconazole

Fluconazole is a medication used to prevent and treat fungal infections. In this clinical trial, it is being studied to find the best way to give it to children and teenagers who have serious fungal infections. The trial is looking at how the body absorbs and processes fluconazole when it is taken by mouth or given through a vein. The goal is to find the most effective dosing plan for young patients aged 2 to 18 years, to help them fight off these infections more effectively.

Fungal infection – Fungal infections are caused by fungi that invade and grow in or on the body. They can affect various parts of the body, including the skin, nails, and lungs. The progression of a fungal infection depends on the type of fungus and the area affected. Common symptoms include itching, redness, and discomfort in the affected area. In some cases, the infection can spread to other parts of the body if not managed. Fungal infections can be persistent and may require ongoing attention to prevent recurrence.

Trial ID:

2024-518305-17-01

Protocol code:

112771

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Fluconazole for Children and Adolescents with Fungal Infections

What is this study about?

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