NCT06574789

Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted at seven major children's hospitals in Australia and New Zealand to test a new approach for treating a virus, called cytomegalovirus in children with weakened immune systems. The researchers want to find out if using a web app to customise the dose of a medication called ganciclovir is better at clearing the virus over a six-week period compared to the standard method of giving the medication.

Detailed description

Immunocompromised children between 1 months to 18 years with cytomegalovirus viraemia who are admitted to one of the participating sites will be enrolled into the trial if eligible (see eligibility criteria) and randomly allocated into two groups. Children in the 'control- standard dosing group' will receive standard intravenous ganciclovir treatment for cytomegalovirus viraemia at a standard dosing of at 5mg/kg IV BD. Children in the "intervention: individualised dosing using a web app group" will receive a personalised intravenous ganciclovir dose calculated using an individualised IV ganciclovir dosing app. This approach considers the patient's weight, creatinine level, and target drug exposure, allowing for tailored dosing based on individual pharmacokinetic parameters. The virological clearance by 6 weeks of the children in each of the two groups will be compared.

Conditions

• Cytomegalovirus Viraemia

Interventions

Type	Name	Description
DRUG	Standard dosing of IV ganciclovir	IV ganciclovir at standard dosing
DRUG	Personalised dosing of IV ganciclovir	IV ganciclovir at a personalised dosing calculated using a ganciclovir dosing web app

Timeline

• Start date: 2024-10-29
• Primary completion: 2028-06-01
• Completion: 2028-12-01
• First posted: 2024-08-28
• Last updated: 2026-04-08

Locations

7 sites across 2 countries: Australia, New Zealand