The ID MAGIC Trial is about finding a better way of treating immunocompromised children with cytomegalovirus (CMV) infections, by seeing if a personalised dose of ganciclovir calculated using a web-based dosing app treats the virus more effectively than the current method of treatment.

This is a new project and will involve approximately 232 children from seven hospitals around Australia and New Zealand. This study has been initiated by the study doctor Associate Professor Amanda Gwee from Murdoch Children’s Research Institute (MCRI) and The Royal Children’s Hospital in Melbourne. It is sponsored by MCRI and has been funded by the Medical Research Future Fund (MRFF).

Once you have been recruited to the trial you will be assigned to either the ‘standard of care’ or the ‘intervention web-based dosing app’ group.

Regardless of which group you are assigned to, you will receive the medication ganciclovir intravenously (given through your vein) to treat your infection.

During the trial you or your child will have blood samples taken to measure how much CMV and ganciclovir is in your blood, as well as other blood markers to look at how the virus is affecting the body and how your body is tolerating the medication.

You will also be asked to complete three online surveys to see how you or your child would describe their general health over the six month period since starting their treatment with ganciclovir.

You or your child can stop taking part at any time. You just need to tell us so. You do not need to tell us the reason why. If you leave the project, we will use any information collected unless you tell us not to.

We are unable to say if there are any direct benefits to you. We expect the main benefits of this study to be for others in the future. We hope that children with CMV infection can receive an effective dose of ganciclovir to improve treatment outcomes and limit side effects in the future.

Medical treatments often have side effects. You or your child may have none, some or all of the side effects listed below. Side effects may be mild, moderate or severe. We will also be looking out for side effects.

Please tell us immediately if your child experiences any new or unusual symptoms.

The side effects of ganciclovir may include:

• Diarrhea
• Nausea
• Vomiting
• Headache
• Fatigue
• Kidney toxicity
• Liver toxicity (rare side effect)
• Injection site reactions
• Low blood cell count

You or your child will be closely monitored by your treating doctors whilst being treated for the CMV infection. If there are any concerns about you or your child’s recovery, this should be discussed with the treating doctor. You can also contact the study team at any time.

As part of the study, we will collect blood samples to measure the amount of CMV and ganciclovir in your blood. Each sample will be labelled with a unique code, which means your identity will not be shared with anyone outside the research team. After the samples have been tested, they will be destroyed.

In this study, we will collect and use your personal and health information for research purposes. We can disclose this information only with your permission, except as required by law. Your information will be stored in secure databases or locked in filing cabinets securely at the participating hospitals.

The following people may access your child’s information as part of this research project:

• The research team involved with this project
• The Royal Children’s Hospital Human Research Ethics Committee
• Therapeutic Goods Administration

Your information will only be identified by researchers at the participating hospitals or research institutes. This means that your name and other personal details will stay on the information while it is used at the hospital. However, we will remove your name and other details that could identify you before we send it to the research team in other Australian hospitals or to the Therapeutic Goods Administration.

You have the right to access and correct the information we collect and store about you. This is in accordance with relevant Australian and/or Victorian privacy and other relevant laws. Please contact us if you would like to access this information.

We plan to publicise findings of this research project in medical journals and at presentations such as conferences and workshops. The presentations could take place in Australia or overseas. Your information will be grouped together with the other children who are taking part in the project. We will present the findings from the project in such a way that you cannot be identified.

If you have any concerns and/or complaints about the project, the way it is being conducted or your rights as a participant and would like to speak to someone independent of the project, please contact:

Director, Research Ethics and Governance

The Royal Children’s Hospital

Phone: show phone number

For any queries, please email the ID MAGIC Trial research team. See 'Contact us' for details.