Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)
NCT Number: NCT06574789
Acronym: ID-MAGIC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cytomegalovirus Viraemia
Interventions: DRUG: Standard dosing of IV ganciclovir|DRUG: Personalised dosing of IV ganciclovir
Sponsor: Murdoch Childrens Research Institute
Sex: ALL
Age: CHILD, ADULT
Enrollment: 232
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2028-12
Locations: Sydney Children's Hospital, Sydney, New South Wales, 2031, Australia|The Children's Hospital at Westmead, Sydney, New South Wales, 2145, Australia|Queensland Children's Hospital, Brisbane, Queensland, 4101, Australia|The Royal Children's Hospital, Melbourne, Victoria, 3052, Australia|Monash Children's Hospital, Melbourne, Victoria, 3168, Australia|Perth Children's Hospital, Perth, Western Australia, 6009, Australia|Starship Children's Hospital, Auckland, North Island, 1023, New Zealand

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.

Primary Outcome Measures: The proportion of participants who achieve CMV virological clearance by 6 weeks, CMV virological clearance by 6 weeks to be compared between the two treatment groups. \* Virological clearance defined as two consecutives negative CMV polymerase chain reaction results, or detectable but CMV viral load is less than the lower limit of detection. Separated by at least 72 hours by 6-weeks (42 days) after randomisation., 42 days
Secondary Outcome Measures: The proportion of participants who achieve CMV virological clearance before 3-weeks, The proportion of children who achieve virological clearance before 3-weeks (21 days) to be compared between the two treatment arms. Virological clearance defined as two consecutives negative CMV polymerase chain reaction results, or detectable but CMV viral load is less than the lower limit of detection. Separated by at least 72 hours., 21 days|The proportion of participants who develop CMV disease by 6 weeks, The proportion of children who develop CMV disease by 6 weeks to be compared between the two treatment groups. CMV disease assessed by the treating clinician based on signs/symptoms of disease followed by microbiological confirmation at the 6-week assessment., 42 days|Difference between treatment groups in All-cause mortality by 6 months, All-cause mortality by 6 months to be compared between the two treatment groups. All-cause mortality assessed by chart ± telephone review by the research team at 6-month timepoint., 6 months|The proportion of participants who develop drug resistant CMV infection by 6 months, The proportion of children who develop drug resistant CMV infection by 6 months to be compared between the two treatment groups. Children with refractory or further CMV infections following resolution of the initial infection will be evaluated for CMV-resistance through gene testing (UL97 and UL54)., 6 months|The proportion of participants with treatment-related adverse effects (AEs), The proportion of children with any treatment-related AEs to be compared between the two treatment groups. Assessed at end of treatment or at 6 weeks (whichever is later) by the treating team., 42 days|Change in Quality of Life measured over 6 months using the EQ-5D-Y Questionnaire., Quality of Life (QoL) over the 6-month period following randomisation to be compared between the two treatment groups using the QoL EQ-5D-Y questionnaire, assessed at 7 days, 42 days and 180 days.

The EQ-5D-Y descriptive system comprises the following five dimensions: mobility, looking after oneself, doing usual activities, having pain or discomfort and feeling worried, sad or unhappy. Each dimension has 3 levels: no problems, some problems and a lot of problems.

The final question measures how good or bad the participants' health is that day on a scale from 0 to 100. 100 means the best health they can imagine and 0 means the worst health they can imagine., 7 days, 42 days, 180 days|Difference between treatment groups in cost-effectiveness over the 6-month period following randomisation, The total sum of all hospital and patient/family resources required per patient over the 6-month period to be compared between the two treatment groups., 6 months