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

Last updated: May 30, 2025
Sponsor: Murdoch Childrens Research Institute
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Personalised dosing of IV ganciclovir

Standard dosing of IV ganciclovir

Clinical Study ID

NCT06574789
107507
  • Ages 1-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Immunocompromised patients including transplant recipients (haematopoietic stem celltransplant (HSCT), solid organ transplant (SOT)), those receiving chemotherapy orother 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 determinesthat 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 trialassessments.

  5. Legally acceptable parent/guardian capable of providing consent on the participant'sbehalf.

  6. Treating clinician agreeable to child being enrolled in the trial.

Exclusion

Exclusion Criteria:

  1. Current or prior CMV infection with documented genotypic resistance to GCV (UL97and/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 theformulation; or

  6. Treating clinician determines that combination antiviral therapy is indicated forCMV infection; or

  7. Has received >3 days of IV GCV or foscarnet or oral valganciclovir for the treatmentof 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 CMVinfection, as part of a clinical trial.

Study Design

Total Participants: 232
Treatment Group(s): 2
Primary Treatment: Personalised dosing of IV ganciclovir
Phase: 2
Study Start date:
October 29, 2024
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Sydney Children's Hospital

    Sydney, New South Wales 2031
    Australia

    Site Not Available

  • The Children's Hospital at Westmead

    Sydney, New South Wales 2145
    Australia

    Active - Recruiting

  • Queensland Children's Hospital

    Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Monash Children's Hospital

    Melbourne, Victoria 3168
    Australia

    Site Not Available

  • The Royal Children's Hospital

    Melbourne, Victoria 3052
    Australia

    Active - Recruiting

  • Perth Children's Hospital

    Perth, Western Australia 6009
    Australia

    Active - Recruiting

  • Starship Children's Hospital

    Auckland, North Island 1023
    New Zealand

    Site Not Available

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