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New treatment option for Cytomegalovirus Viraemia
Official title Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)
ClinicalTrials.gov ID: NCT06574789
What this study is testing
What is Standard dosing of IV ganciclovir?
Standard dosing of IV ganciclovir is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cytomegalovirus viraemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- Immunocompromised patients including transplant recipients (haematopoietic stem cell transplant (HSCT), solid organ transplant (SOT)), those...
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- Immunocompromised patients including transplant recipients (haematopoietic stem cell transplant (HSCT), solid organ transplant (SOT)), those receiving chemotherapy or other immunosuppression or those with a...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Brisbane, Queensland, Australia
- Melbourne, Victoria, Australia
- Perth, Western Australia, Australia
- Auckland, North Island, New Zealand
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Brisbane, Queensland, Australia; Melbourne, Victoria, Australia; Perth, Western Australia, Australia; Auckland, North Island, New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.