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RecruitingPhase 2NCT06574789

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

Sponsor

Murdoch Childrens Research Institute

Enrollment

232 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

Cytomegalovirus Viraemia

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 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

Min Age: 1 MonthMax Age: 18 Years

Inclusion Criteria6

  • 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 Criteria9

  • 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.

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Interventions

DRUGStandard dosing of IV ganciclovir

IV ganciclovir at standard dosing

DRUGPersonalised dosing of IV ganciclovir

IV ganciclovir at a personalised dosing calculated using a ganciclovir dosing web app

Locations(7)

Sydney Children's Hospital

Sydney, New South Wales, Australia

The Children's Hospital at Westmead

Sydney, New South Wales, Australia

Queensland Children's Hospital

Brisbane, Queensland, Australia

The Royal Children's Hospital

Melbourne, Victoria, Australia

Monash Children's Hospital

Melbourne, Victoria, Australia

Perth Children's Hospital

Perth, Western Australia, Australia

Starship Children's Hospital

Auckland, North Island, New Zealand

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NCT06574789