Optimizing Ganciclovir Dosing for Immunocompromised Children with CMV

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

This study is testing a new way to give ganciclovir to immunocompromised children with CMV to see if personalized dosing helps them clear the virus better than standard dosing.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 232 (estimated)
• Ages: 1 Month to 18 Years
• Sex: All
• Sponsor: Murdoch Childrens Research Institute (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 7 sites (Sydney, New South Wales and 6 other locations)
• Trial ID: NCT06574789 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate a new method for treating cytomegalovirus (CMV) in immunocompromised children by using a web app to customize the dosage of ganciclovir. Children aged 1 month to 18 years with detectable CMV viraemia will be randomly assigned to receive either standard dosing or individualized dosing based on their specific health parameters. The study will compare the effectiveness of these two approaches in clearing the virus over a six-week period. Conducted across seven major children's hospitals in Australia and New Zealand, this trial seeks to improve treatment outcomes for vulnerable pediatric patients.

Who should consider this trial

Good fit: Ideal candidates include immunocompromised children, such as those who have undergone stem cell or organ transplants, or those receiving chemotherapy.

Not a fit: Patients with documented resistance to ganciclovir or severe renal impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatment for children with CMV, potentially improving their recovery and overall health.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in optimizing drug dosing for other conditions, suggesting potential for success.

Eligibility criteria

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.

Where this trial is running

Sydney, New South Wales and 6 other locations

• Sydney Children's Hospital — Sydney, New South Wales, Australia (Recruiting)
• The Children's Hospital at Westmead — Sydney, New South Wales, Australia (Recruiting)
• Queensland Children's Hospital — Brisbane, Queensland, Australia (Recruiting)
• The Royal Children's Hospital — Melbourne, Victoria, Australia (Recruiting)
• Monash Children's Hospital — Melbourne, Victoria, Australia (Recruiting)
• Perth Children's Hospital — Perth, Western Australia, Australia (Recruiting)
• Starship Children's Hospital — Auckland, North Island, New Zealand (Recruiting)

Study contacts

• Principal investigator: Amanda Gwee — Murdoch Childrens Research Institute
• Study coordinator: Alice Lei

Conditions Cytomegalovirus Viraemia