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

Launched by MURDOCH CHILDRENS RESEARCH INSTITUTE · Aug 26, 2024

Keywords

ClinConnect Summary

The Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC) is a research study aimed at developing a better way to treat cytomegalovirus (CMV) infections in children with weakened immune systems. This trial is happening at seven children's hospitals in Australia and New Zealand. Researchers want to see if using a special web app to personalize the dose of a medication called ganciclovir can help clear the virus more effectively over six weeks compared to the usual dosing method.

To participate, children must be immunocompromised, which means their immune systems are not working well due to conditions like organ transplants or chemotherapy. They also need to have a significant CMV infection that requires treatment. Parents or guardians must agree to let their child take part in the study, and the child should be able to attend follow-up visits. The trial is currently looking for participants, and those who qualify will receive close monitoring and personalized care during the treatment process. If you think your child might be eligible or you have any questions, it’s best to talk to their doctor for more information.

Gender

ALL

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.