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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
232
IV ganciclovir at standard dosing
IV ganciclovir at a personalised dosing calculated using a ganciclovir dosing web app
Sydney Children's Hospital
Sydney, New South Wales, Australia
RECRUITINGThe Children's Hospital at Westmead
Sydney, New South Wales, Australia
RECRUITINGQueensland Children's Hospital
Brisbane, Queensland, Australia
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.
Time frame: 42 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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The Royal Children's Hospital
Melbourne, Victoria, Australia
RECRUITINGMonash Children's Hospital
Melbourne, Victoria, Australia
RECRUITINGPerth Children's Hospital
Perth, Western Australia, Australia
RECRUITINGStarship Children's Hospital
Auckland, North Island, New Zealand
RECRUITINGTime frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months