Status:
RECRUITING
Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)
Lead Sponsor:
Murdoch Childrens Research Institute
Conditions:
Cytomegalovirus Viraemia
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
Brief Summary
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 syst...
Detailed Description
Immunocompromised children between 1 months to 18 years with cytomegalovirus viraemia who are admitted to one of the participating sites will be enrolled into the trial if eligible (see eligibility cr...
Eligibility Criteria
Inclusion
- 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.
- Legally acceptable parent/guardian capable of providing consent on the participant's behalf.
- Treating clinician agreeable to child being enrolled in the trial.
Exclusion
- 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
- History of allergy, or adverse reaction to GCV, aciclovir or any component of the formulation; or
- Treating clinician determines that combination antiviral therapy is indicated for CMV infection; or
- Has received \>3 days of IV GCV or foscarnet or oral valganciclovir for the treatment of CMV infection prior to enrolment; or
- Prior enrolment in the trial; or
- Current recipient of another investigational product used for the treatment of CMV infection, as part of a clinical trial.
Key Trial Info
Start Date :
October 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT06574789
Start Date
October 29 2024
End Date
December 1 2028
Last Update
December 3 2025
Active Locations (7)
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1
Sydney Children's Hospital
Sydney, New South Wales, Australia, 2031
2
The Children's Hospital at Westmead
Sydney, New South Wales, Australia, 2145
3
Queensland Children's Hospital
Brisbane, Queensland, Australia, 4101
4
The Royal Children's Hospital
Melbourne, Victoria, Australia, 3052