Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age

Summary

This study aimed to learn what levels of rezafungin were in the blood after dosing and how safe it was, in children and adolescents below 18 years old who were already receiving treatment for a fungal infection, a suspected fungal infection or at risk of fungal infection. The main question the researchers wanted to answer in this trial was: • What were the levels of rezafungin in the blood after the participants were dosed? The researchers also wanted to know what medical problems happened during this trial. The participants in this trial received one dose of rezafungin on day 1 through a needle into a vein, called an intravenous (IV) infusion. The dose of rezafungin was measured in milligrams (mg) and given to the participants according to their body weight in kilograms (mg/kg). The doctors checked the participants' health and asked questions about what medications they were taking and took blood samples to check the levels of rezafungin in the participants' blood. After receiving the treatment at day 30, the doctors checked the participants' health. This was an "open-label" trial. This means each participant knew what they were receiving, and the doctors and trial staff also knew.

Timeline

Start

2023-09-13

Primary completion

2024-05-23

Completion

2024-10-14

Drugs

Indications