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Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)

PHASE2RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

Has received >3 days of IV GCV or foscarnet or oral valganciclovir for the treatment of CMV infection prior to enrolment; or

Prior enrolment in the trial; or

Current recipient of another investigational product used for the treatment of CMV infection, as part of a clinical trial.

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Eligibility

Age eligible for study : 1 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-10-29

Primary completion: 2028-06-01

Study completion finish: 2028-12-01

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT06574789

Intervention or treatment

DRUG: Standard dosing of IV ganciclovir

DRUG: Personalised dosing of IV ganciclovir

Conditions

• Cytomegalovirus Viraemia

Image related to Cytomegalovirus Viraemia

Condition: Cytomegalovirus Viraemia
DRUG: Standard dosing of IV ganciclovir and other drugs
Perth, Western Australia, Australia and more
Sponsor: Murdoch Childrens Research Institute

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Perth Children's Hospital

Research sites nearby

Select from list below to view details:

Perth Children's Hospital
Perth, Western Australia, Australia
Sydney Children's Hospital
Sydney, New South Wales, Australia
The Children's Hospital at Westmead
Sydney, New South Wales, Australia
Queensland Children's Hospital
Brisbane, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Control: standard dosing Enrolled participant will receive standard dosing of IV Ganciclovir dependent on renal function: * CrCl \>/= 70mL/min: 5 mg/kg IV 12 hourly * CrCl \>/= 50-69: 2.5 mg/kg/ IV 12 hourly * CrCl \>/= 25-49: 2.5 mg/kg IV 24 hourly	DRUG: Standard dosing of IV ganciclovir IV ganciclovir at standard dosing
ACTIVE_COMPARATOR: Intervention: individualised dosing using a web app Enrolled participant will receive a personalised dosing of IV Ganciclovir calculated using an individualised IV ganciclovir dosing app, that considers the patient's weight, creatinine level, and at a target drug exposure (AUC24 between 40-100 mg.h/L), allowing for tailored dosing based on individual pharmacokinetic parameters.	DRUG: Personalised dosing of IV ganciclovir IV ganciclovir at a personalised dosing calculated using a ganciclovir dosing web app

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)