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.
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.
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
Parallel
Standard dosing of IV ganciclovir
DrugIV ganciclovir at standard dosing
Personalised dosing of IV ganciclovir
DrugIV ganciclovir at a personalised dosing calculated using a ganciclovir dosing web app
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.
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.
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.
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.
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).
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