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

RecruitingPhase 2Ages 1 Month - 18 YearsAllMurdoch Childrens Research Institute
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

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

7 sites
Sydney Children's Hospital
Sydney, Australia
The Children's Hospital at Westmead
Sydney, Australia
Queensland Children's Hospital
Brisbane, Australia
The Royal Children's Hospital
Melbourne, Australia
Monash Children's Hospital
Melbourne, Australia
Perth Children's Hospital
Perth, Australia
Starship Children's Hospital
Auckland, New Zealand
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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