Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC) (NCT06574789) | Clinical Trial Compass
RecruitingPhase 2
Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)
Australia232 participantsStarted 2024-10-29
Plain-language 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.
Who can participate
Age range1 Month – 18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Detectable clinically significant CMV viraemia and treating clinician determines that antiviral therapy is indicated.
✓. Willing to partake in the trial
✓. Willing/able to attend all follow up visits and capable of completing all trial assessments.
✓. Legally acceptable parent/guardian capable of providing consent on the participant's behalf.
✓. Treating clinician agreeable to child being enrolled in the trial.
Exclusion criteria
✕. Current or prior CMV infection with documented genotypic resistance to GCV (UL97 and/or UL54); or
✕. Severe renal impairment (defined as estimated glomerular filtration rate (eGFR) \<25mL/min); or
✕. Congenital CMV infection; or
✕. Life expectancy of less than 7 days as determined by the treating physician; or
✕. History of allergy, or adverse reaction to GCV, aciclovir or any component of the formulation; or
✕. Treating clinician determines that combination antiviral therapy is indicated for CMV infection; or
What they're measuring
1
The proportion of participants who achieve CMV virological clearance by 6 weeks