Optimizing Ganciclovir Dosing for Immunocompromised Children with CMV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Amanda Gwee — Murdoch Childrens Research Institute
• Study coordinator: Alice Lei
• Email: alice.lei2@rch.org.au
• Phone: +61 0433 903 448

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.