Not recruitingRare disease

Study on Rezafungin Acetate for Children with Fungal Infections Aged Birth to Under 18 Years

Verified siteInvestigationalNo 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 studying fungal infections in children from birth to under 18 years of age. The treatment being tested is a medication called Rezafungin Acetate, which is given as an intravenous infusion, meaning it is administered directly into the bloodstream through a vein. This study aims to understand how the body processes this medication and to assess its safety and how well it is tolerated by children who are already receiving other antifungal treatments to prevent or treat fungal infections.

The study will involve giving a single dose of Rezafungin Acetate to participants and monitoring them to see how the medication is absorbed, distributed, and eliminated by the body. Researchers will also keep a close eye on any side effects or changes in health that might occur during the study. This will help determine if the medication is safe and effective for use in children with fungal infections.

Throughout the study, participants will undergo various health checks, including blood tests and heart monitoring, to ensure their safety. The information gathered from this trial will contribute to understanding the potential benefits and risks of using Rezafungin Acetate in young patients with fungal infections.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the purpose and procedures involved. This study is designed to evaluate the effects of a single dose of rezafungin acetate in children and teenagers who are receiving other antifungal treatments.
Step 2
Receiving the medication
You will receive a single dose of rezafungin acetate through an intravenous infusion. This means the medication will be given directly into your vein using a needle. The dose will be 200 mg, and it is provided as a powder that is mixed into a solution before being administered.
Step 3
Monitoring and assessments
After receiving the medication, you will be monitored closely. This includes checking your vital signs, such as heart rate and blood pressure, and conducting laboratory tests on your blood and urine. These tests help ensure your safety and check how your body is responding to the medication.
You may also have an electrocardiogram (ECG), which is a test that records the electrical activity of your heart, to look for any changes.
Step 4
Follow-up visits
You will have follow-up visits scheduled to continue monitoring your health and the effects of the medication. These visits are important to ensure your safety and to gather information about how the medication is working in your body.

Who can join the trial?

3 criteria

Participants must be children from birth up to 18 years old.
Both boys and girls can participate.
Participants must be receiving systemic antifungal medication. This means they are taking medicine, either by mouth or through an IV, to prevent or treat a fungal infection.

Who cannot join the trial?

8 criteria

Patients with known allergies to the study medication or its ingredients cannot participate.
Patients who are currently participating in another clinical trial are not eligible.
Patients with severe liver or kidney problems are excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients with a history of drug or alcohol abuse may not participate.
Patients with certain heart conditions are not eligible.
Patients who have received certain medications that might interfere with the study drug are excluded.
Patients with any other medical condition that the study doctors believe would make participation unsafe are not eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Verified
Goethe University Frankfurt
Frankfurt, Germany
Verified
Hospital Universitario 12 De Octubre
Madrid, Spain

Trial locations

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Investigated drugs

Rezafungin Acetate is a medication used in this clinical trial to help prevent or treat fungal infections in children. Fungal infections can be serious, especially in people with weakened immune systems. This medication is given through an IV, which means it is delivered directly into the bloodstream. The trial is focused on understanding how the body processes this medication and ensuring it is safe and well-tolerated by children from birth up to 18 years old. By studying this, researchers hope to confirm that rezafungin acetate can be an effective option for protecting against or treating fungal infections in young patients.

Rezafungin Acetate

What is already known about the treatment

Rezafungin Acetate – Rezafungin Acetate is administered as an intravenous (IV) infusion, meaning it is given directly into a vein. It is currently being studied in clinical trials to understand its safety and how it moves through the body in children from birth to under 18 years old who are receiving other antifungal medications to prevent or treat fungal infections. The main use of Rezafungin Acetate is to treat fungal infections, which are illnesses caused by fungi. At the molecular level, it works by interfering with the cell wall of the fungus, which is essential for the fungus's survival, ultimately leading to its death. Rezafungin Acetate is classified as an antifungal medication.

Investigated diseases

Fungal Infections – Fungal infections are caused by fungi, which are microorganisms that can invade and grow in various parts of the body. These infections can affect the skin, nails, lungs, or other organs, depending on the type of fungus involved. The progression of a fungal infection often begins with the fungus entering the body through inhalation, a cut, or other means. Once inside, the fungus can multiply and spread, leading to symptoms such as redness, itching, or more severe systemic effects. The severity and progression of the infection depend on the type of fungus and the individual's immune response. Some fungal infections may remain localized, while others can become invasive, affecting multiple body systems.