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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-18
SponsorMurdoch Childrens Research Institute

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Standard dosing of IV ganciclovir
  • Personalised dosing of IV ganciclovir

Treatment groups

232 Participants
are divided into 2 treatment groups