Clinical trial NCT06574789: Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)
Official title: Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cytomegalovirus Viraemia
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 232
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Immunocompromised patients including transplant recipients (haematopoietic stem cell transplant (HSCT), solid organ transplant (SOT)), those receiving chemotherapy or other immunosuppression or those with a known/suspected inborn error of immunity (determined by an immunologist); and
2. Detectable clinically significant CMV viraemia and treating clinician determines that antiviral therapy is indicated.
3. Willing to partake in the trial
4. Willing/able to attend all follow up visits and capable of completing all trial assessments.
5. Legally acceptable parent/guardian capable of providing consent on the participant's behalf.
6. Treating clinician agreeable to child being enrolled in the trial.

Exclusion Criteria:

1. Current or prior CMV infection with documented genotypic resistance to GCV (UL97 and/or UL54); or
2. Severe renal impairment (defined as estimated glomerular filtration rate (eGFR) \<25mL/min); or
3. Congenital CMV infection; or
4. Life expectancy of less than 7 days as determined by the treating physician; or
5. History of allergy, or adverse reaction to GCV, aciclovir or any component of the formulation; or
6. Treating clinician determines that combination antiviral therapy is indicated for CMV infection; or
7. Has received \>3 days of IV GCV or foscarnet or oral valganciclovir for the treatment of CMV infection prior to enrolment; or
8. Prior enrolment in the trial; or
9. Current recipient of another investigational product used for the treatment of CMV infection, as part of a clinical trial.

Primary outcomes:
measure: The proportion of participants who achieve CMV virological clearance by 6 weeks
timeFrame: 42 days
Secondary outcomes:
measure: The proportion of participants who achieve CMV virological clearance before 3-weeks
timeFrame: 21 days
measure: The proportion of participants who develop CMV disease by 6 weeks
timeFrame: 42 days
measure: Difference between treatment groups in All-cause mortality by 6 months
timeFrame: 6 months
measure: The proportion of participants who develop drug resistant CMV infection by 6 months
timeFrame: 6 months
measure: The proportion of participants with treatment-related adverse effects (AEs)
timeFrame: 42 days
measure: Change in Quality of Life measured over 6 months using the EQ-5D-Y Questionnaire.
timeFrame: 7 days, 42 days, 180 days
measure: Difference between treatment groups in cost-effectiveness over the 6-month period following randomisation
timeFrame: 6 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Sydney Children's Hospital
state: New South Wales
city: Sydney
country: Australia
facility: The Children's Hospital at Westmead
state: New South Wales
city: Brisbane
country: Australia
facility: Queensland Children's Hospital
state: Queensland
city: Melbourne
country: Australia
facility: The Royal Children's Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Monash Children's Hospital
state: Victoria
city: Perth
country: Australia
facility: Perth Children's Hospital
state: Western Australia
city: Auckland
country: New Zealand
facility: Starship Children's Hospital
state: North Island
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Amanda Gwee
role: PRINCIPAL_INVESTIGATOR
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