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Study on Posaconazole for Treating Fungal Infections in Children Under 2 Years

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 studying a type of infection called invasive fungal infection, which can be serious and is caused by fungi entering the body. The study is testing a medication called Posaconazole, also known by its code name MK-5592. Posaconazole is used to treat fungal infections and is being tested in two forms: an oral suspension, which is a liquid taken by mouth, and a solution for infusion, which is given through a vein. The purpose of the study is to understand how the body processes Posaconazole in young children under the age of two who have these infections.

The study will involve children who are suspected or confirmed to have an invasive fungal infection. Participants will receive Posaconazole either as an oral suspension or through an intravenous infusion. The study will monitor how the medication is absorbed and processed in the body, as well as its safety and any side effects. The study is divided into different panels, with some children receiving a single dose and others receiving multiple doses over a period of time.

Throughout the study, researchers will collect information on how the medication affects the children, including any adverse events or side effects. The study aims to provide valuable information on the use of Posaconazole in very young children, which could help improve treatment options for those with serious fungal infections. The study is expected to continue until 2025, allowing researchers to gather comprehensive data on the medication's effects in this age group.

The research process

The trial runs in 6 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, the participant must have a central line, such as a central venous catheter, in place or planned to be in place before beginning the study treatment.
The participant must weigh at least 500 grams and have provided documented informed consent through a legally acceptable representative.
Step 2
Treatment initiation
The study involves the administration of posaconazole, which is used to treat fungal infections.
Participants are divided into two panels: Panel A and Panel B.
Step 3
Panel a treatment
In Panel A, participants receive a single dose of posaconazole through an intravenous injection.
The study measures the average concentration, maximum concentration, time to maximum concentration, and clearance of the drug in the body.
Step 4
Panel b treatment
In Panel B, participants receive multiple doses of posaconazole either through intravenous injection or as an oral suspension.
The study measures similar parameters as in Panel A, including the average concentration and maximum concentration of the drug.
Step 5
Monitoring and evaluation
Throughout the study, participants are monitored for any adverse events or side effects related to the treatment.
The study also evaluates the need for additional antifungal therapy and tracks all-cause mortality through 28 days in Panel B.
Step 6
Study completion
The study is estimated to conclude by September 22, 2025.
Participants will have contributed to understanding the safety and effectiveness of posaconazole in treating fungal infections in young children.

Who can join the trial?

5 criteria

For Panel A: The patient is receiving treatment for a possible, probable, or confirmed **invasive fungal infection**. This means a serious fungal infection that affects deeper tissues or organs, and it should be caused by fungi that the study drug, **posaconazole (POS)**, can fight against. This can include a type of infection called **candidiasis**.
For Panel B: The patient has a diagnosis, assessed by a doctor, of a possible, probable, or confirmed **invasive fungal infection**. This infection should be caused by fungi that the study drug, **posaconazole (POS)**, can fight against, but it cannot include **candidiasis**.
The patient has a **central line** in place or plans to have one before starting the study treatment. A central line is a special tube placed into a large vein to give medicines or fluids.
The patient weighs at least **500 grams**.
The patient or their legally acceptable representative has given written permission to participate in the study, known as **informed consent**.

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Verified sites

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

Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium
Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

Trial locations

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Investigated drugs

Posaconazole (POS, MK-5592) is a medication being studied for its ability to treat invasive fungal infections in young children. In this trial, it is given in two forms: an intravenous (IV) form and a powder for oral suspension. The study aims to understand how the medication is processed in the bodies of children under 2 years old and to assess its safety and tolerability.

Posaconazole

What is already known about the treatment

Posaconazole – Posaconazole is administered either intravenously or as a powder for oral suspension. It is currently being studied in clinical trials, particularly for its use in young children under two years of age with invasive fungal infections. The main therapeutic indication for posaconazole is the treatment of fungal infections. At the molecular level, posaconazole works by inhibiting the synthesis of ergosterol, a vital component of fungal cell membranes, thereby disrupting cell membrane integrity and leading to the death of the fungal cells. It is classified pharmacologically as an antifungal agent.

Investigated diseases

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. These infections can range from mild, such as athlete's foot, to more severe forms like invasive aspergillosis. The progression of a fungal infection depends on the type of fungus and the individual's immune system. Symptoms may include itching, redness, and discomfort in the affected area. In more serious cases, the infection can spread to other parts of the body, leading to more complex health issues.