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Smart app tailors virus drug for vulnerable kids

NCT ID NCT06574789

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 232 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

1 month to 18 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    7 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Monash Children's Hospital

    RECRUITING

    Melbourne, Victoria, 3168, Australia

  • Perth Children's Hospital

    RECRUITING

    Perth, Western Australia, 6009, Australia

  • Queensland Children's Hospital

    RECRUITING

    Brisbane, Queensland, 4101, Australia

  • Starship Children's Hospital

    RECRUITING

    Auckland, North Island, 1023, New Zealand

  • Sydney Children's Hospital

    RECRUITING

    Sydney, New South Wales, 2031, Australia

  • The Children's Hospital at Westmead

    RECRUITING

    Sydney, New South Wales, 2145, Australia

  • The Royal Children's Hospital

    RECRUITING

    Melbourne, Victoria, 3052, Australia