Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574789
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial ID-MAGIC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial ID-MAGIC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ID-MAGIC
Brief Summary:
This study is being conducted at seven major childrens 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 5mgkg 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None