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

April 2, 2026 updated by: Murdoch Childrens Research Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

232

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Queensland Children's Hospital
        • Contact:
    • Victoria
      • Melbourne, Victoria, Australia, 3168
      • Melbourne, Victoria, Australia, 3052
        • Recruiting
        • The Royal Children's Hospital
        • Contact:
        • Principal Investigator:
          • Amanda Gwee, MBBS
    • Western Australia
  • New Zealand
    • North Island

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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 Measures

Outcome Measure
Measure Description
Time Frame
The proportion of participants who achieve CMV virological clearance by 6 weeks
Time Frame: 42 days
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 Measures

Outcome Measure
Measure Description
Time Frame
The proportion of participants who achieve CMV virological clearance before 3-weeks
Time Frame: 21 days
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
Time Frame: 42 days
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
Time Frame: 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
Time Frame: 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)
Time Frame: 42 days
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.
Time Frame: 7 days, 42 days, 180 days

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
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Murdoch Childrens Research Institute

Investigators

  • Principal Investigator: Amanda Gwee, Murdoch Childrens Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107507

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Beginning 12 months following analysis and article publication, upon approval of the request, the following will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access:

  • Individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices)
  • Trial protocol, Statistical Analysis Plan, PICF

IPD Sharing Time Frame

Beginning 12 months following analysis and article publication, upon approval of the request

IPD Sharing Access Criteria

Researchers must be from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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