Smart app tailors virus drug for vulnerable kids
NCT ID NCT06574789
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a web app that customizes the dose of the antiviral drug ganciclovir can clear cytomegalovirus (CMV) faster in 232 children with weakened immune systems. Participants are recruited from seven hospitals in Australia and New Zealand. The goal is to see if personalized dosing works better than the standard approach over six weeks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 232 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 month to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Monash Children's Hospital
RECRUITINGMelbourne, Victoria, 3168, Australia
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Perth Children's Hospital
RECRUITINGPerth, Western Australia, 6009, Australia
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Queensland Children's Hospital
RECRUITINGBrisbane, Queensland, 4101, Australia
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Starship Children's Hospital
RECRUITINGAuckland, North Island, 1023, New Zealand
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Sydney Children's Hospital
RECRUITINGSydney, New South Wales, 2031, Australia
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The Children's Hospital at Westmead
RECRUITINGSydney, New South Wales, 2145, Australia
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The Royal Children's Hospital
RECRUITINGMelbourne, Victoria, 3052, Australia